A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI

April 14, 2026 updated by: R-Pharm

Multicenter, Double-blind, Randomized, Comparative Study of the Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With With Metastatic Colorectal Cancer (mCRC) With Wild-type RAS as First-line Therapy in Combination With FOLFIRI

The primary objective of this study is to demonstrate equivalence of pharmacokinetic properties, and comparability of safety and immunogenicity parameters of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI. The additional objective is to perform a pilot evaluation of the efficacy of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, double-blind, randomized, comparative, phase I study

Treatment with panitumumab in combination with FOLFIRI (de Gramont) within of this study will continue for up to 2 years or disease progression/unacceptable toxicity/patient refusal to continue therapy (in whichever comes first)

The study will include the following periods:

  1. Screening period: days -27 to 0 (up to 1 administration of the study therapy)

    If a tumor biopsy is required for histological diagnosis verification and testing of KRAS/NRAS, BRAF mutation status, Her2/neu status, and MSI status, the screening period may be extended up to 42 days

  2. Main period: days 1 to 182

    Eligible patients will be randomized at the ratio of 1:1 to one of the two study arms: RPH-030 and Vectibix®. During the Main Period of the study, patients will receive panitumumab (RPH-030 or Vectibix®) at a dose of 6 mg/kg intravenously (IV) once every 2 weeks (2 weeks = 1 cycle) in combination with FOLFIRI (after 8 cycles, patients will be switched to the de Gramont regimen)

    Therapy during the Main Study Period will continue until the earliest of the following:

    • Completion of 6 months (up to 13 cycles inclusive)
    • Disease progression (according to RECIST 1.1 criteria or clinical progression)
    • Development of unacceptable toxicity
    • Patient's withdrawal of consent to continue treatment

    Tumor response assessment during the Main Study Period will be performed approximately every 6 weeks

    Patients will be hospitalized at least twice: at Visit 1 (Day 1) and Visit 3 (Day 29) either before drug administration or on the eve of it; the duration of hospitalization will be at least 24 hours from the start of panitumumab infusion

  3. Period of continued therapy: days 183 to 365

    During the period of continued therapy, all patients will receive RPH-030 therapy, including those patients who received Vectibix® therapy during the Main Period

    Therapy during this period will continue until the earliest of the following:

    • Up to 1 year of therapy
    • Disease progression (according to RECIST 1.1 criteria or clinical progression)
    • Development of unacceptable toxicity
    • Patient's withdrawal of consent to continue treatment

    Assessment of the tumor response to therapy during the period of continued therapy will be performed approximately once every 8 weeks

  4. Treatment Extension Period: days 366 to 729

    Participants in the Treatment Extension Period will be patients who demonstrate stable disease (SD) or tumor response after 1 year of therapy. The decision to enter this period will be made by the investigator

    Therapy during the Treatment Extension Period will continue until the earliest of the following:

    • For a total duration of up to 2 years
    • Disease progression (according to RECIST 1.1 criteria or clinical progression)
    • Development of unacceptable toxicity
    • Patient's withdrawal of consent to continue treatment
  5. Follow-up period (follow-up/FU)

For patients who complete the Treatment Extension Period (either as scheduled or prematurely), a Follow-up visit will be scheduled 28 ± 3 days after the last dose of panitumumab. Following this visit, the patient's participation in the study will be considered complete

Follow-up (FU) visits will be conducted every 8 weeks (±7 days) until Day 365, death, or withdrawal of consent (whichever occurs first):

  • For patients who discontinue study therapy due to disease progression or start a new line of treatment (including surgery), FU will be conducted via telephone contact with the patient or relatives to collect overall survival data
  • For patients who discontinue study therapy for reasons other than progression and have not started new treatment, FU will include CT/MRI assessments until disease progression, initiation of new therapy, or Day 365. Once progression occurs or new therapy starts, these patients will switch to telephone survival follow-up

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
      • Arkhangelsk, Russia, 163045
        • Recruiting
        • State Budgetary Healthcare Institution of the Arkhangelsk Region "Arkhangelsk Oncology Dispensary"
        • Contact:
      • Istra, Russia, 143515
        • Recruiting
        • Moscow City Oncology Hospital No. 62 (MGOB 62)
        • Contact:
      • Ivanovo, Russia, 153051
        • Recruiting
        • Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
        • Contact:
      • Kaluga, Russia, 248007
        • Recruiting
        • State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"
        • Contact:
      • Kazan', Russia, 420029
        • Recruiting
        • State Autonomous Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
        • Contact:
      • Kemerovo, Russia, 650036
        • Recruiting
        • State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")
        • Contact:
      • Krasnodar, Russia, 350040
        • Recruiting
        • State Budgetary Healthcare Organisation "Clinical Oncology Dispensary No. 1" under the Ministry of Healthcare of Krasnodar region
        • Contact:
      • Kursk, Russia, 305524
        • Recruiting
        • Regional Budgetary Healthcare Institution "Kursk Oncology Research and Clinical Center named after G.E. Ostroverkhov"
        • Contact:
      • Kuz'molovskiy, Russia, 191104
        • Recruiting
        • State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"
        • Contact:
      • Moscow, Russia, 111123
        • Recruiting
        • The Loginov Moscow Clinical Scientific Center (MCSC)
        • Contact:
      • Moscow, Russia, 115522
        • Recruiting
        • N.N. Blokhin National Medical Research Center of Oncology (Blokhin NRC of Oncology)
        • Contact:
      • Moscow, Russia, 117152
        • Recruiting
        • Oncology Center No. 1 of the City Clinical Hospital named after S.S. Yudin of the Moscow Healthcare Department
        • Contact:
      • Moscow, Russia, 119435
        • Recruiting
        • I.M. Sechenov First Moscow State Medical University (Sechenov University)
        • Contact:
      • Moscow, Russia, 121205
        • Recruiting
        • Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")
        • Contact:
      • Moscow, Russia, 125367
        • Recruiting
        • Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation
        • Contact:
      • Moscow, Russia, 127521
        • Recruiting
        • Research Lab LLC
        • Contact:
      • Moscow, Russia, 143442
        • Recruiting
        • Joint-Stock Company "Medsi Group of Companies"
        • Contact:
      • Novosibirsk, Russia, 630091
        • Recruiting
        • Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"
        • Contact:
      • Obninsk, Russia, 249032
        • Recruiting
        • Federal State Budgetary Healthcare Institution "Clinical Hospital No. 8 of the Federal Medical-Biological Agency of Russia"
        • Contact:
      • Obninsk, Russia, 249036
        • Recruiting
        • Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, Branch: P.A. Herzen Moscow Research Oncology Institute
        • Contact:
      • Omsk, Russia, 644013
        • Recruiting
        • Omsk Region Budgetary Healthcare Institution "Clinical Oncology Dispensary"
        • Contact:
      • Saint Petersburg, Russia, 195271
        • Recruiting
        • Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of Saint-Petersburg"
        • Contact:
      • Saint Petersburg, Russia, 198255
        • Recruiting
        • City Clinical Oncology Dispensary (Saint Petersburg)
        • Contact:
      • Tula, Russia, 300039
        • Recruiting
        • State Health Institution "Tula Regional Clinical Oncology Dispensary"
        • Contact:
      • Volgograd, Russia, 400138
        • Recruiting
        • State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"
        • Contact:
      • Yaroslavl, Russia, 150054
        • Recruiting
        • State Institution of Healthcare of Yaroslavl Region "Regional Oncology Hospital"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. A voluntarily signed and dated Informed Consent form (ICF) of the patient
  2. Histologically verified (documented results of respective examinations available) metastatic colorectal adenocarcinoma (in case the results of previous examinations are not available, the diagnosis will be verified in the central laboratory during screening upon receipt and evaluation of the results before randomization)
  3. Patient consent to undergo a screening biopsy if archival tissue samples are unavailable for histological diagnosis verification
  4. Patients with metastatic colorectal cancer (mCRC), either de novo metastatic or recurrent with distant metastases, who are candidates for first-line therapy
  5. RAS wild-type (WT) status
  6. ECOG status 0-1
  7. Presence of at least one measurable lesion according to RECIST 1.1 criteria (patients with a single measurable bone lesion are not eligible)
  8. Absence or resolution of toxic effects from prior therapy (neoadjuvant/adjuvant) or surgical complications to ≤ Grade 1 according to CTCAE v5.0, except for chronic/irreversible adverse events that do not impact the safety profile of the study treatment (e.g., alopecia)
  9. Serum magnesium ≥ 0.66 mmol/L, total calcium ≥ 2.15 mmol/L, and potassium ≥ 3.5 mmol/L at the time of randomization
  10. Life expectancy of ≥ 13 weeks from the time of randomization (as per the investigator's assessment)
  11. Agreement of patients of childbearing potential to remain abstinent from heterosexual intercourse or use highly effective methods of contraception starting from the date of signing the ICF, throughout the treatment period, and for 6 months after the last dose of FOLFIRI and 2 months after the last infusion of panitumumab. Female participants are considered not of childbearing potential if they have experienced permanent cessation of menstruation (self-reported) established retrospectively after 12 months of natural amenorrhea with appropriate clinical status, such as age (range 45-55 years)
  12. Ability to comply with protocol procedures in the opinion of the investigator
  13. For patients participating in the pharmacokinetic study, body weight must be within 50-100 kg at the time of informed consent signing

Exclusion Criteria:

  1. Prior systemic antitumor therapy (except for neoadjuvant or adjuvant fluoropyrimidine-based chemotherapy)
  2. Prior therapy with anti-EGFR monoclonal antibodies (e.g., cetuximab, panitumumab) or small molecule EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, afatinib)
  3. Concomitant systemic immunotherapy or hormonal cancer therapy, or concurrent use of other cancer treatments not specified in the Protocol
  4. Major surgery within 28 days, or radiotherapy (except for palliative radiotherapy) with residual signs of radiation toxicity within 14 days prior to the planned date of randomization
  5. Presence of BRAF gene mutation (if BRAF testing results are unavailable, testing will be performed at a central laboratory; results must be obtained and evaluated prior to randomization)
  6. Severe comorbidities or life-threatening acute complications of the underlying disease (including massive pleural, pericardial, or peritoneal effusion requiring intervention)
  7. Paralytic ileus, gastrointestinal obstruction, or uncontrolled diarrhea (disabling symptoms despite adequate treatment)
  8. Central nervous system (CNS) metastases that are progressive, symptomatic (e.g., cerebral edema, spinal cord compression), or requiring glucocorticosteroids at doses >10 mg/day (prednisolone equivalent), >1.5 mg/day (dexamethasone equivalent), or anticonvulsants, whereas patients with treated and stable brain metastases (for ≥4 weeks), asymptomatic non-progressive lesions not requiring steroids/anticonvulsants for ≥4 weeks, or newly diagnosed asymptomatic lesions requiring no therapy may be included

  9. Ongoing comorbidities at the time of screening that increase the risk of adverse events during study therapy, including:

    • Stable angina pectoris (Canadian Cardiovascular Society Grade III-IV), unstable angina, or a history of myocardial infarction within 1 month prior to the planned date of randomization
    • Clinically significant cardiac arrhythmias (patients with controlled heart rate/rhythm are eligible)
    • Chronic heart failure (New York Heart Association [NYHA] Class III-IV)
    • Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite antihypertensive therapy)
    • Severe respiratory failure
    • Current severe uncontrolled systemic disease
    • Any other medical condition or comorbidity that, in the investigator's opinion, significantly increases the risk of adverse events during the study
  10. Gilbert's syndrome at randomization or in medical history

  11. Hematologic abnormalities:

    • Absolute neutrophil count (ANC) <1.5 × 10^9/L
    • Platelet count <100 × 10^9/L
    • Hemoglobin <90 g/L

  12. Renal impairment:

    - Serum creatinine >1.5 × ULN or Glomerular Filtration Rate (GFR) <45 mL/min (calculated via CKD-EPI formula)

  13. Hepatic impairment:

    • Total bilirubin ≥ 1.5 × ULN
    • AST or ALT ≥ 3.0 ULN (≥ 5 × ULN for patients with liver metastases)
    • Alkaline phosphatase (ALP) ≥ 5 × ULN
  14. Feasibility of radical resection of all metastatic lesions
  15. History of other malignancies that are progressive or required treatment within 5 years prior to signing the ICF, excluding radically treated cervical carcinoma in situ, breast cancer in situ, or basal/squamous cell skin carcinoma
  16. Conditions limiting the patient's ability to comply with protocol requirements (e.g., dementia, neurological or psychiatric disorders, drug addiction (excluding the use of narcotic analgesics for pain management), alcohol dependence, etc.). Religious or personal beliefs that may potentially limit standard therapies within the study (e.g., refusal of blood transfusions) are considered conditions limiting protocol compliance
  17. Concurrent participation in other interventional clinical trials, participation in other clinical trials within 30 days prior to signing the ICF (provided the patient received at least one dose of investigational therapy), or prior participation in this clinical trial (provided the patient received at least one dose of panitumumab)
  18. Acute infectious diseases or exacerbation of chronic infections within 28 days prior to the planned date of randomization
  19. Major surgery within 28 days prior to the planned date of randomization. Major surgery is defined as procedures involving entry into a major body cavity (abdomen, chest, or skull) performed under general anesthesia. Placement of a venous port system for antitumor therapy or an intestinal stoma is not considered major surgery
  20. Positive test result for any of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (anti-HCV), antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1 and anti-HIV-2), or a blood test for syphilis at screening or within 3 months prior to the planned date of randomization
  21. Inability to receive intravenous (IV) administration of the investigational product
  22. Contraindication to any type of intravenous contrast enhancement (non-contrast chest CT is permitted if medically indicated)
  23. Current continuous daily treatment with corticosteroids at doses >10 mg/day (prednisolone equivalent) or >1.5 mg/day (dexamethasone equivalent), excluding topical steroids
  24. Hypersensitivity to any components of the study drugs specified in the protocol or intolerance to any premedication drugs
  25. History of hypersensitivity to monoclonal antibody (mAb) therapies
  26. Pregnancy or breastfeeding
  27. Consumption of more than 10 units of alcohol per week or a history of alcoholism or drug addiction. One unit of alcohol is defined as 250 mL of beer, 125 mL of wine, or 30 mL of spirits
  28. Presence of any other significant comorbidities or conditions that, in the reasonable opinion of the Investigator, may adversely affect the patient's participation and well-being in the study and/or confound the evaluation of study results
  29. Inability to perform venous blood sampling or to insert a venous catheter required for biosample collection (applicable to patients enrolled in the pharmacokinetic study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil

Panitumumab 6 mg/kg IV every 2 weeks (Q2W). Infusion duration: 60±5 minutes for Cycles 1-3 (PK assessment) and 30-60 minutes thereafter. Combined with FOLFIRI: Irinotecan 180 mg/m² (90±5 min infusion), Calcium Folinate 400 mg/m² (2-hour infusion), followed by 5-Fluorouracil (5-FU) 400 mg/m² bolus and a 46-hour continuous infusion of 5-FU 2400 mg/m² (1200 mg/m²/day). After 8 cycles of chemotherapy according to the FOLFIRI regimen, the patient is transferred to chemotherapy in the modified de Gramont regimen (irinotecan withdrawal)

Premedication (e.g., prednisolone, antiemetic) is mandatory before the administration of chemotherapy drugs; no premedication is required before the administration of panitumumab
Drug: RPH-030

RPH-030: concentrate for solution for infusion, 20 mg/mL

Panitumumab is diluted in 0.9% sodium chloride for injection under aseptic conditions. The volume required to achieve a dose of 6 mg/kg is withdrawn from the vial and added to a total volume of 100 mL. The final concentration must not exceed 10 mg/mL

Other Names:
  • panitumumab
Drug: Irinotecan

Irinotecan: concentrate for solution for infusion, 20 mg/mL

The required amount of Irinotecan should be diluted in either 5% dextrose solution or 0.9% sodium chloride solution for injection

Drug: Calcium Folinate
Calcium Folinate: solution for intravenous and intramuscular administration, 10 mg/mL
Drug: Fluorouracil

Fluorouracil: solution for intravascular administration, 50 mg/mL

The required amount of Fluorouracil should be diluted in either 5% dextrose solution or 0.9% sodium chloride solution for injection
Active Comparator: Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil

Panitumumab 6 mg/kg IV every 2 weeks (Q2W). Infusion duration: 60±5 minutes for Cycles 1-3 (PK assessment) and 30-60 minutes thereafter. Combined with FOLFIRI: Irinotecan 180 mg/m² (90±5 min infusion), Calcium Folinate 400 mg/m² (2-hour infusion), followed by 5-Fluorouracil (5-FU) 400 mg/m² bolus and a 46-hour continuous infusion of 5-FU 2400 mg/m² (1200 mg/m²/day). After 8 cycles of chemotherapy according to the FOLFIRI regimen, the patient is transferred to chemotherapy in the modified de Gramont regimen (irinotecan withdrawal)

Premedication (e.g., prednisolone, antiemetic) is mandatory before the administration of chemotherapy drugs; no premedication is required before the administration of panitumumab
Drug: Irinotecan

Irinotecan: concentrate for solution for infusion, 20 mg/mL

The required amount of Irinotecan should be diluted in either 5% dextrose solution or 0.9% sodium chloride solution for injection

Drug: Calcium Folinate
Calcium Folinate: solution for intravenous and intramuscular administration, 10 mg/mL
Drug: Fluorouracil

Fluorouracil: solution for intravascular administration, 50 mg/mL

The required amount of Fluorouracil should be diluted in either 5% dextrose solution or 0.9% sodium chloride solution for injection

Drug: Vectibix®

Vectibix®: concentrate for solution for infusion, 20 mg/mL

Panitumumab is diluted in 0.9% sodium chloride for injection under aseptic conditions. The volume required to achieve a dose of 6 mg/kg is withdrawn from the vial and added to a total volume of 100 mL. The final concentration must not exceed 10 mg/mL

Other Names:
  • panitumumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the pharmacokinetic curve "concentration-time" (AUC(0-336)) of panitumumab
Time Frame: Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Area under the pharmacokinetic curve "concentration-time" of panitumumab after the first (single dose) administration, truncated at the point before the second administration, i.e. up to 336 hours
Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (AUC tau ss)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (after the third administration) (AUC tau ss)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum serum concentration of panitumumab after the first administration (Cmax)
Time Frame: Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Maximum serum concentration of panitumumab after the first administration (Cmax)
Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Maximum serum concentration of panitumumab at steady state (Cmax ss)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Maximum serum concentration of panitumumab at steady state (after the third administration) (Cmax ss)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Minimum serum concentration of panitumumab at steady state (Cmin ss)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Minimum serum concentration of panitumumab at steady state (in three administrations) (Cmin ss)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Residual concentration of panitumumab at steady state (Ctrough)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Residual concentration of panitumumab at steady state (before the third administration) (Ctrough)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Time Frame: Up to day 729
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Up to day 729
Proportion of patients (%) with adverse events (AEs) of any severity
Time Frame: Up to day 729
Proportion of patients (%) with adverse events (AEs) of any severity
Up to day 729
Proportion of patients (%) with AEs of severity grade ≥ 3
Time Frame: Up to day 729
Proportion of patients (%) with AEs of severity grade ≥ 3 according to CTCAE 5.0
Up to day 729
Proportion of patients (%) with ADRs of severity grade ≥ 3
Time Frame: Up to day 729
Proportion of patients (%) with ADRs of severity grade ≥ 3 according to CTCAE 5.0
Up to day 729
Proportion of patients (%) with serious adverse events (SAEs)
Time Frame: Up to day 729
Proportion of patients (%) with serious adverse events (SAEs)
Up to day 729
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Time Frame: Up to day 729
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Up to day 729
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs
Time Frame: Up to day 729
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs
Up to day 729
Proportion of patients (%) who developed anti-drug antibodies (ADA) to panitumumab
Time Frame: Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose
Proportion of patients (%) who developed anti-drug antibodies (ADA) to panitumumab
Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose
Proportion of patients (%) who developed neutralizing antibodies (NAb) to panitumumab
Time Frame: Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose
Proportion of patients (%) who developed neutralizing antibodies (NAb) to panitumumab
Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose
Proportion of patients (%) developing dermatologic toxicity
Time Frame: Up to day 729
Proportion of patients (%) developing dermatologic toxicity
Up to day 729

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the pharmacokinetic curve "concentration-time" (AUC(0-∞)) of panitumumab
Time Frame: Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Area under the pharmacokinetic curve "concentration-time" of panitumumab after the first administration to infinity (AUC(0-∞))
Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Time to reach the maximum concentration of panitumumab in the blood serum after the first administration (Tmax)
Time Frame: Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Time to reach the maximum concentration of panitumumab in the blood serum after the first administration (Tmax)
Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Elimination half-life of panitumumab after the first administration (T1/2)
Time Frame: Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Elimination half-life of panitumumab after the first administration (T1/2)
Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Volume of distribution of panitumumab after the first administration (Vd)
Time Frame: Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Volume of distribution of panitumumab after the first administration (Vd)
Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Elimination rate constant of panitumumab after the first administration (Kel)
Time Frame: Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Elimination rate constant of panitumumab after the first administration (Kel)
Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose
Area under the pharmacokinetic curve "concentration-time" of panitumumab to infinity at steady state (AUC(0-∞) ss)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Area under the pharmacokinetic curve "concentration-time" of panitumumab to infinity at steady state (AUC(0-∞) ss)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Time to reach the maximum concentration of panitumumab at steady state (Tmax ss)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Time to reach the maximum concentration of panitumumab at steady state (after the third administration) (Tmax ss)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Elimination half-life of panitumumab at steady state (T1/2 ss)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Elimination half-life of panitumumab at steady state (after the third administration) (T1/2 ss)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Volume of distribution of panitumumab at steady state (Vd ss)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Volume of distribution of panitumumab at steady state (after the third administration) (Vd, ss)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Elimination rate constant of panitumumab at steady state (Kel ss)
Time Frame: Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Elimination rate constant of panitumumab at steady state (after the third administration) (Kel ss)
Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose
Objective response rate (%) (ORR) for a period of up to 6 months of therapy inclusive
Time Frame: once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main period

The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria:

  • Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be < 10 mm
  • Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks compared with the baseline sum at screening
once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main period
Disease control rate (DCR) (%)
Time Frame: once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main period

Disease control rate (DCR) (%) for a period of up to 6 months of therapy inclusive

The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria:

  • Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be <10 mm
  • Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements
  • Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study
once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main period
Progression-free survival (PFS) expressed as the rate (%) of 6-month PFS
Time Frame: Up to day 182

Progression-free survival (PFS) expressed as the rate (%) of 6-month PFS

PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause
Up to day 182
Progression-free survival (PFS) expressed as the median PFS for a period of up to 6 months of therapy inclusive
Time Frame: Up to day 182

Progression-free survival (PFS) expressed as the median PFS for a period of up to 6 months of therapy inclusive

PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause
Up to day 182
Objective response rate (%) (ORR) (non-comparative evaluation in the RPH-030 group)
Time Frame: once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main Period; on days 225 (week 33), 281 (week 41), 337 (week 49) of the Period of continued therapy

Objective response rate (%) (ORR) for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-030 group)

The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria:

  • Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be < 10 mm
  • Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks compared with the baseline sum at screening
once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main Period; on days 225 (week 33), 281 (week 41), 337 (week 49) of the Period of continued therapy
Disease control rate (DCR) (%) (non-comparative evaluation in the RPH-030 group)
Time Frame: once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main Period; on days 225 (week 33), 281 (week 41), 337 (week 49) of the Period of continued therapy

Disease control (DCR) (%) within a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-030 group)

The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria:

  • Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be <10 mm
  • Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements
  • Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study
once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main Period; on days 225 (week 33), 281 (week 41), 337 (week 49) of the Period of continued therapy
Progression-free survival (PFS) (non-comparative evaluation in the RPH-030 group)
Time Frame: Up to day 351

Progression-free survival (PFS) expressed as the rate (%) of 1-year PFS (non-comparative evaluation in the RPH-030 group)

PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause
Up to day 351
Progression-free survival (PFS) (non-comparative evaluation in the RPH-030 group)
Time Frame: Up to day 351

Progression-free survival (PFS) expressed as the median PFS for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-030 group)

PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause
Up to day 351
Overall survival (OS) (non-comparative evaluation in the RPH-030 group)
Time Frame: Up to day 351
Overall survival (OS) expressed as the rate (%) of 1-year OS (non-comparative evaluation in the RPH-030 group)
Up to day 351
Overall survival (OS) (non-comparative evaluation in the RPH-030 group)
Time Frame: Up to day 351
Overall survival (OS) expressed as the median OS for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-030 group)
Up to day 351

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Pharm

Investigators

  • Study Director: Mikhail Samsonov, R-Pharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL01790199

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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