- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05688605
A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors
January 15, 2023 updated by: Shanghai Miracogen Inc.
An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MRG003 in Combination With HX008 in Patients With EGFR-positive Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors.
Study Overview
Detailed Description
This study consists of two parts: Phase I and Phase II.
The objective of this study is to assess the safety and tolerability of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors; and to explore the maximum tolerated dose (MTD) and to determine the recommended phase II dose (RP2D) of combination therapy; and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Phase 2
- 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 Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Ruihua Xu, M.D.
- Phone Number: 86-18127912775
- Email: xurh@sysucc.org.cn
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-
Hunan
-
Changsha, Hunan, China, 410029
- Not yet recruiting
- Hunan Cancer Hospital
-
Contact:
- Yingrui Shi, M.D.
- Phone Number: 13607441956
- Email: shiyingrui@hnca.org.cn
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing to sign the informed consent form and follow the requirements specified in the protocol.
- Aged 18 to 75 (including 18 and 75), both genders.
- BMI ≥17
- Life expectancy ≥ 12 weeks.
- Patients with EGFR-positive advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC), squamous cell carcinoma of head and neck (SCCHN), and nasopharyngeal carcinoma (NPC).
- EGFR-positive determined by immunohistochemistry (except NSCLC, SCCHN and NPC).
- Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- The score of ECOG for performance status is 0 or 1.
- No severe cardiac dysfunction.
- Acceptable liver, renal, and hematologic function.
- Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
Exclusion Criteria:
- History of hypersensitivity to any component of the investigational product.
- Prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy, investigational drugs, attenuated live vaccines, immunomodulators, CYP3A4 inhibitors/inducers, antibody-drug conjugates, Received major surgery without complete recovery, etc.
- Treatment with MMAE/MMAF ADC drugs
- Central nervous system metastasis.
- Toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment ≥ 2 (CTCAE v5.0)
- Presence of peripheral neuropathy ≥ Grade 2.
- Liver function Child Pugh Grade B or Grade C。
- Pleural and peritoneal effusion or pericardial effusion with clinical symptoms requiring drainage.
- Poorly controlled systemic diseases (hypertension and hyperglycemia, etc.)
- Evidence of active infection of hepatitis B, hepatitis C or HIV.
- Patients with poorly controlled heart diseases
- History of ophthalmic abnormalities.
- History of severe skin disease requiring oral or intravenous therapy.
- History of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- Active, known or suspected autoimmune disease or drug related immune disease or the disease history within the past 2 years.
- The patient is using immunosuppressant or systemic hormone therapy.
- Patients with any past arteriovenous bleeding within 3 months or current history of coagulation disorder.
- Any clinically significant VTE occurred within 6 months.
- Received allogeneic tissue/solid organ transplantation.
- Inoculate live vaccine within 30 days before the first dose.
- Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.
- History of other primary malignant tumor diseases.
- Investigator considers which not suitable to participate in the clinical trial
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRG003+HX008
MRG003 will be administrated via intravenous infusion at 1.5, 2.0 mg/kg (MTD=2.5 mg/kg) once on Day 1 of every 3 weeks (21-day cycle). HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day cycle). |
Administered intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD)
Time Frame: Within 21 days after the first dose of the last patient of the MTD group
|
MTD is the highest dose with the proportion of DLT less than 1/3
|
Within 21 days after the first dose of the last patient of the MTD group
|
Recommended Phase II Dose (RP2D)
Time Frame: Baseline to study completion (up to 12 months)
|
The dose level of MRG003 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
|
Baseline to study completion (up to 12 months)
|
Objective Response Rate (ORR)
Time Frame: Baseline to study completion (up to 12 months)
|
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR).
ORR will be assessed by investigator according to RECIST v1.1.
|
Baseline to study completion (up to 12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events (AEs)
Time Frame: Baseline to 30 days after the last dose of study treatment
|
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
|
Baseline to 30 days after the last dose of study treatment
|
Duration of Response (DOR)
Time Frame: Baseline to study completion (up to 12 months)
|
DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
|
Baseline to study completion (up to 12 months)
|
Progression Free Survival (PFS)
Time Frame: Baseline to study completion (up to 12 months)
|
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
|
Baseline to study completion (up to 12 months)
|
Overall Survival (OS)
Time Frame: Baseline to study completion (up to 12 months)
|
OS is defined as the duration from the start of treatment to death of any cause.
|
Baseline to study completion (up to 12 months)
|
Disease Control Rate (DCR)
Time Frame: Baseline to study completion (up to 12 months)
|
DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.
|
Baseline to study completion (up to 12 months)
|
Immunogenicity (ADA)
Time Frame: Baseline to 90 days after the last dose.
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The proportion of patients with positive ADA results.
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Baseline to 90 days after the last dose.
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Serious Adverse Events (SAEs)
Time Frame: Baseline to 90 days after the last dose of study treatment
|
Adverse events that are difficult to deal with in clinical drug research
|
Baseline to 90 days after the last dose of study treatment
|
PK parameters: concentration-time curve
Time Frame: Baseline to 90 days after the last dose.
|
Plot of drug concentration changing with time after drug administration
|
Baseline to 90 days after the last dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 30, 2022
Primary Completion (Anticipated)
May 1, 2025
Study Completion (Anticipated)
July 1, 2025
Study Registration Dates
First Submitted
January 6, 2023
First Submitted That Met QC Criteria
January 15, 2023
First Posted (Actual)
January 18, 2023
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 15, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HX008/MRG003-C001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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