- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05426369
A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT)
June 23, 2022 updated by: Sichuan Clover Biopharmaceuticals, Inc.
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Preliminary Efficacy and Pharmacokinetics of SCB-219M in the Patients With Chemotherapy-induced Thrombocytopenia
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Preliminary Efficacy and Pharmacokinetics of SCB-219M in the patients with chemotherapy-induced thrombocytopenia (CIT)
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
76
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
- Name: Minmin Han
- Email: minmin.han@cloverbiopharma.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China
- Recruiting
- West China Hospital of Sichuan University
-
Contact:
- Yongsheng Wang, MD
- Email: wangy756@163.com
-
-
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
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 ~ 75 years of age (inclusive), willing to participate in this study and sign the informed consent form, and attend the visits throughout the study;
- Body weight ≥ 45 kg;
- Dose escalation stage: Histopathologically or cytopathologically confirmed malignant solid tumors; Dose expansion stage: Histopathologically or cytopathologically confirmed malignant solid tumors (including but not limited to ovarian cancer, non-small cell lung cancer, breast cancer, colorectal cancer, and urinary bladder cancer);
- Dose escalation stage: Patients who are receiving paclitaxel or gemcitabine alone or in combination with platinum (e.g., cisplatin and carboplatin). The chemotherapy regimen may be combined with targeted therapy at the discretion of the investigator; Dose expansion stage: Patients who are receiving chemotherapy for 21 days as a cycle, with the cytotoxic chemotherapy regimen including at least one of the following drugs: antimetabolites, including gemcitabine, etc.; platinum drugs, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; anthracyclines, including adriamycin, daunorubicin, epirubicin, etc.; alkylating agents, including cyclophosphamide, ifosfamide, etc.; or other cytotoxic chemotherapy drugs that can cause thrombocytopenia. The chemotherapy regimen may be combined with targeted therapy or immunotherapy at the discretion of the investigator;
- Dose escalation stage: PLT count within 30 × 109 ~ 75 × 109/L (inclusive) in the chemotherapy cycle prior to enrollment; Dose expansion stage: PLT count within 30 × 109 ~ 75 × 109/L (inclusive) in the chemotherapy cycle prior to enrollment; there are two PLT counts within the above range, and the time interval between the two PLT counts is at least 24 hours;
- Ability to receive the same chemotherapy regimen as the previous cycle of chemotherapy (dose delay or dose adjustment of chemotherapy due to PLT decrease is acceptable);
- Toxicities related to prior anti-tumor treatment have decreased to ≤ Grade 2 (CTCAE version 5.0) before enrollment (except for alopecia barbae, alopecia and subjective description of symptoms);
- ECOG PS score: 0 ~ 2;
- A life expectancy of at least 3 months, as assessed by the investigator;
Hematology, blood chemistry, and coagulation function at enrollment:
- 75 × 109/L ≤ PLT count ≤ 200 × 109/L;
- PT/APTT/INR within 80% -120% (inclusive) of the normal range;
- Absolute neutrophil count ≥ 1.5 × 109/L;
- Hemoglobin ≥ 90 g/L (no red blood cell transfusion and no use of erythropoiesis-stimulating agents within 14 days);
- Albumin ≥ 25 g/L;
- Renal function at screening: serum creatinine ≤ 1.5 × ULN and creatinine clearance > 40 mL/min;
Liver function at screening:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (or ≤ 5 × ULN in case of liver metastasis);
- Total bilirubin ≤ 2 × ULN unless a subject has Gilbert's syndrome or asymptomatic cholelithiasis;
- Eligible subjects of childbearing potential (male and female) must agree to use a reliable method of contraception during the study and for at least 90 days after the last dose; female subjects of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test within 28 days prior to enrollment; male subjects are not allowed to donate sperm from the first dose to 90 days after the last dose; Acceptable methods of contraception include: total abstinence; double barrier method (e.g. condom plus diaphragm with spermicide); use of intrauterine devices (IUDs) or hormonal contraceptives (e.g. oral drugs, implants, transdermal patches, hormonal vaginal devices or extended-Release injections), or hysterectomy/bilateral salpingectomy/bilateral tubal ligation in female subjects of childbearing potential or sexual partners of male subjects; and vasectomy or confirmed azoospermia in male subjects or sexual partners of female subjects.
Exclusion Criteria:
- Pregnant or lactating women;
- Known allergies to protein drugs (e.g., recombinant proteins, and monoclonal antibodies) or excipients of the investigational product;
- Acute infections not clinically controlled and requiring intravenous antibiotics;
- Treatment with recombinant human thrombopoietin (rh-TPO) or recombinant human interleukin 11 (rh IL-11) within 10 days before the first dose; or treatment with thrombopoietin receptor agonist (TPO-RA) within 1 month before the first dose;
- Patients who have received anticoagulant or antiplatelet drugs (such as warfarin, cyclocoumarol, etc., aspirin requiring a washout period for ≥ 7 days) within 5 terminal half-lives before the first dose or need to continue to receive these drugs during the study;
- Clinically significant thrombocytopenia related to non-tumor chemotherapeutic drugs within 6 months prior to screening as assessed by the investigator, including but not limited to ethylenediaminetetraacetic acid (EDTA) -dependent pseudothrombocytopenia, hypersplenism, infection, bleeding, etc.; clinically significant bleeding events within 2 weeks prior to screening; platelet transfusion within 7 days before the first dose;
- Hematological diseases, including leukemia, primary immune thrombocytopenia (ITP), essential thrombocytosis, myeloproliferative disorders, multiple myeloma and myelodysplastic syndrome;
- Known solid tumors with splenic metastasis or bone metastasis with a potential effect on bone marrow hematopoiesis as assessed by the investigator;
- Splenectomy;
Severe cardiovascular disease (or history) as assessed by the investigator at screening:
- Previous congestive heart failure, and current New York Heart Association (NYHA) functional class III/IV;
- Diseases associated with increased thrombotic events (e.g., atrial fibrillation, atrial flutter, unstable angina);
- QTc > 470 ms (or QTc > 480 ms for subjects with bundle branch block);
- Myocardial infarction in the past 6 months;
- A subject using a pacemaker or defibrillator can be included in case of normal cardiac function;
- Known coagulopathy, or arteriovenous thrombotic disease (e.g., stroke, deep vein thrombosis, pulmonary embolism) in the past 6 months, or transient ischemic attack in the past 6 months;
- Major surgery or radiotherapy within 4 weeks before the first dose, unless radiotherapy-related toxicities have decreased to ≤ Grade 2 (CTCAE version 5.0) (patients with > Grade 2 alopecia barbae, alopecia, or subjective description of symptoms can be included in this study);
- Patients with active central nervous system or leptomeningeal metastases or who have failed local therapy for these diseases; however, the subjects with asymptomatic brain metastases are allowed to be enrolled.
- Poorly controlled hypertension at screening as defined by SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg measured at 2-hour intervals at rest;
- Subjects with a positive history of human immunodeficiency virus (HIV) antibody or a positive HIV serological test at screening; subjects with active hepatitis B infection, i.e. positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV DNA) > lower limit of detection at screening; subjects with seropositive hepatitis C virus (HCV) antibody and HCV-RNA > lower limit of detection;
- Live vaccines within 4 weeks before the first dose (among SARS-CoV-2 vaccines, subjects having received adenovirus vaccine should be evaluated by the investigator for inclusion, while subjects having received other types of SARS-CoV-2 vaccines are allowed for inclusion);
- Subjects who have participated in any clinical study of other drugs or devices within 4 weeks before the first dose, or plan to do so during the study;
- Poor compliance or other factors that are considered unsuitable for the study in the opinion of the investigator.
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: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dose Escalation
For single dose escalation, the dose level will be 2µg/kg -15 µg/kg.
|
Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein for injection (Strength: 1 mg/ml, 0.5ml/vial)
|
EXPERIMENTAL: Dose Expansion - Group A
For dose expansion, the dose level is recommended to be the bioeffective dose obtained from dose escalation and administered once weekly (group A) for a treatment cycle(21 days).
|
Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein for injection (Strength: 1 mg/ml, 0.5ml/vial)
|
EXPERIMENTAL: Dose Expansion - Group B
For dose expansion, the dose level is recommended to be the bioeffective dose obtained from dose escalation and administered once weekly ( group B )for a treatment cycle(21 days).
|
Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein for injection (Strength: 1 mg/ml, 0.5ml/vial)
|
EXPERIMENTAL: Dose Expansion - Group C
For dose expansion, the dose level is recommended to be the bioeffective dose obtained from dose escalation and administered twice weekly (C group) for a treatment cycle(21 days).
|
Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein for injection (Strength: 1 mg/ml, 0.5ml/vial)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose escalation: Occurrence of DLT.
Time Frame: Occurrence of DLT from enrollment to day 21.
|
Occurrence of DLT from enrollment to day 21.
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Dose escalation: Frequency of DLT.
Time Frame: Frequency of DLT from enrollment to day 21.
|
Frequency of DLT from enrollment to day 21.
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Dose escalation and Dose expansion: Occurrence of adverse events during treatment
Time Frame: AEs will be collected up to day 63.
|
AEs will be collected up to day 63.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose escalation: Cmax
Time Frame: up to 21 days after treatment
|
Cmax : Maximum serum concentration
|
up to 21 days after treatment
|
Dose escalation: Cmax/D
Time Frame: up to 21 days after treatment
|
Cmax/D :Dose normalized Cmax
|
up to 21 days after treatment
|
Dose escalation: tmax
Time Frame: up to 21 days after treatment
|
tmax : Time to Cmax
|
up to 21 days after treatment
|
Dose escalation: AUC0-24h
Time Frame: up to 21 days after treatment
|
AUC0-24h: Area under the serum concentration-time curve from 0 h to 24 h
|
up to 21 days after treatment
|
Dose escalation: AUC0-last
Time Frame: up to 21 days after treatment
|
AUC0-last :Area under the serum concentration-time curve from 0 h on Day 1 to the last time point with a quantifiable concentration
|
up to 21 days after treatment
|
Dose escalation: AUC0-inf
Time Frame: up to 21 days after treatment
|
AUC0-inf : Area under the serum concentration-time curve from 0 h extrapolated to infinity
|
up to 21 days after treatment
|
Dose escalation: t1/2
Time Frame: up to 21 days after treatment
|
t1/2 : Apparent half-life
|
up to 21 days after treatment
|
Dose escalation: CL/F
Time Frame: up to 21 days after treatment
|
CL/F: Systemic clearance
|
up to 21 days after treatment
|
Dose escalation: Vz/F
Time Frame: up to 21 days after treatment
|
Vz/F: Volume of distribution
|
up to 21 days after treatment
|
Dose escalation: λz
Time Frame: up to 21 days after treatment
|
λz: Elimination rate constant
|
up to 21 days after treatment
|
Dose escalation: Preliminary efficacy assessment.The percentage of subjects requiring platelet infusion and the frequency of infusion during the DLT observation period.
Time Frame: up to 28 days after administration
|
up to 28 days after administration
|
|
Dose escalation: Preliminary efficacy assessment. Duration of PLT count ≥50×10^9/L and percentage of subjects during the DLT observation period.
Time Frame: up to 28 days after administration
|
up to 28 days after administration
|
|
Dose escalation: Preliminary efficacy assessment. Duration of PLT count ≥75×10^9/L and percentage of subjects during the DLT observation period.
Time Frame: up to 28 days after administration
|
up to 28 days after administration
|
|
Dose escalation: Preliminary efficacy assessment. Duration of PLT count ≥100×10^9/L and percentage of subjects during the DLT observation period.
Time Frame: up to 28 days after administration
|
up to 28 days after administration
|
|
Dose expansion: C0
Time Frame: up to 168 hours after the last treatment
|
C0: The concentration before administration (within 1 hour before administration)
|
up to 168 hours after the last treatment
|
Dose expansion: C24
Time Frame: up to 168 hours after the last treatment
|
C24: Concentration at 24 h after administration
|
up to 168 hours after the last treatment
|
Dose expansion: Cmax
Time Frame: up to 168 hours after the last treatment
|
Cmax : Maximum concentration
|
up to 168 hours after the last treatment
|
Dose expansion: Cmax/D
Time Frame: up to 168 hours after the last treatment
|
Cmax/D : Dose normalized Cmax
|
up to 168 hours after the last treatment
|
Dose expansion: Cmin ss
Time Frame: up to 168 hours after the last treatment
|
Cmin ss: Minimum steady state concentration
|
up to 168 hours after the last treatment
|
Dose expansion: Cav ss
Time Frame: up to 168 hours after the last treatment
|
Cav ss: Average steady state concentration
|
up to 168 hours after the last treatment
|
Dose expansion: Rac
Time Frame: up to 168 hours after the last treatment
|
Rac: Accumulation ratio
|
up to 168 hours after the last treatment
|
Dose expansion: tmax
Time Frame: up to 168 hours after the last treatment
|
tmax : Time to Cmax
|
up to 168 hours after the last treatment
|
Dose expansion: AUC0-last
Time Frame: up to 168 hours after the last treatment
|
AUC0-last :AUC to the last quantifiable concentration
|
up to 168 hours after the last treatment
|
Dose expansion: AUC0-inf
Time Frame: up to 168 hours after the last treatment
|
AUC0-inf : AUC extrapolated to infinity
|
up to 168 hours after the last treatment
|
Dose expansion: t1/2
Time Frame: up to 168 hours after the last treatment
|
t1/2 : Apparent half-life
|
up to 168 hours after the last treatment
|
Dose expansion: CL/F
Time Frame: up to 168 hours after the last treatment
|
CL/F: Systemic clearance
|
up to 168 hours after the last treatment
|
Dose expansion: Vz/F
Time Frame: up to 168 hours after the last treatment
|
Vz/F: Volume of distribution
|
up to 168 hours after the last treatment
|
Dose expansion: λz
Time Frame: up to 168 hours after the last treatment
|
λz: Elimination rate constant
|
up to 168 hours after the last treatment
|
Dose expansion: Preliminary efficacy assessment. Incidence of grade 3/4 thrombocytopenia (CTCAE version 5.0).
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
|
Dose expansion: Preliminary efficacy assessment. The percentage of subjects requiring platelet infusion and the frequency of infusion in each treatment cycle.
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
|
Dose expansion: Preliminary efficacy assessment. Change in platelet nadir from the previous qualifying cycle to the treatment cycle.
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
|
Dose expansion: Preliminary efficacy assessment. The percentage of subjects without dose reduction > 20% in the next cycle of chemotherapy due to thrombocytopenia after the first cycle of chemotherapy.
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
|
Dose expansion: Preliminary efficacy assessment. The percentage of subjects without dose delay > 4 days in the next cycle of chemotherapy due to thrombocytopenia after the first cycle of chemotherapy.
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
|
Dose expansion: Preliminary efficacy assessment. Duration of PLT count ≥50×10^9/L and percentage of subjects after treatment.
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
|
Dose expansion: Preliminary efficacy assessment. Duration of PLT count ≥75×10^9/L and percentage of subjects after treatment.
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
|
Dose expansion: Preliminary efficacy assessment. Duration of PLT count ≥100×10^9/L and percentage of subjects after treatment.
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
|
Dose expansion: Preliminary efficacy assessment. Percentage of subjects not requiring platelet infusion or other platelet-raising agents (rh-TPO or rh IL-11, etc.) at the end of the second treatment cycle.
Time Frame: up to 63 days after administration
|
up to 63 days after administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 14, 2022
Primary Completion (ANTICIPATED)
June 1, 2024
Study Completion (ANTICIPATED)
June 1, 2024
Study Registration Dates
First Submitted
May 10, 2022
First Submitted That Met QC Criteria
June 15, 2022
First Posted (ACTUAL)
June 22, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 29, 2022
Last Update Submitted That Met QC Criteria
June 23, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLO-SCB-219M-CHN-001
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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