A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer
Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of MRG007 Combination Therapy in Patients With Advanced Colorectal Cancer
1 other identifier
interventional
316
1 country
1
Brief Summary
This is a Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MRG007 combination therapy in patients with advanced colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
July 30, 2026
July 1, 2026
2.3 years
July 27, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Dose Limiting Toxicity (DLT)
From the first dose to 30 days after the last dose
Serious Adverse Events (SAEs)
From the first dose to 30 days after the last dose
Adverse Event (AE)
From the first dose to 30 days after the last dose
Recommended Phase 2 Dose(RP2D) and/or Maximum Tolerated Dose (MTD)
From the first dose to 30 days after the last dose
Objective Response Rate (ORR)
Assessments will be performed every 6 weeks (± 7 days) following the first dose.
Secondary Outcomes (5)
PK/Immunogenicity
up to 2 yesrs
Duration of Response (DOR)
Through study completion, an average 2 years
Disease Control Rate (DCR)
Through study completion, an average 2 years
Progression-Free Survival (PFS)
Through study completion, an average 2 years
Overall Survival (OS)
Through study completion, an average 2 years
Study Arms (4)
MRG007+5-Fluorouracil/Leucovorin Calcium+Bevacizumab
EXPERIMENTALMRG007+5-Fluorouracil/Leucovorin Calcium+ Oxaliplatin+Bevacizumab
EXPERIMENTALMRG007+5-Fluorouracil/Leucovorin Calcium+ Oxaliplatin+PD-1/VEGFPD-1/VEGF antibody
EXPERIMENTALMRG007+Capecitabine+ Oxaliplatin+Bevacizumab
EXPERIMENTALInterventions
MRG007 will be administrated as specified in the protocol.
5-Fluorouracil/Leucovorin Calcium will be administrated as specified in the protocol.
Bevacizumab will be administrated as specified in the protocol.
Oxaliplatin will be administrated as specified in the protocol.
PD-1/VEGF antibody will be administrated as specified in the protocol.
Capecitabine will be administrated as specified in the protocol.
Eligibility Criteria
You may qualify if:
- Expected survival of ≥ 3 months.
- Tumor tissue specimens must be provided for relevant biomarker testing. If archived tissue specimens are unavailable, a new biopsy must be performed.
- Pathologically confirmed, unresectable locally advanced or metastatic colorectal adenocarcinoma.
- At least one measurable lesion according to RECIST v1.1 criteria. Measurable lesions should not have received prior radiotherapy; however, measurable lesions located within a prior radiation field or after local therapy may be selected as target lesions if disease progression is confirmed.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ function must be demonstrated.
- Sexually active males and females of childbearing potential must agree to use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Females of childbearing potential include premenopausal females and postmenopausal females within 1 year after menopause. Females of childbearing potential must have a negative serum pregnancy test result ≤ 7 days prior to the first dose and before randomization.
You may not qualify if:
- Trial participants with known deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H).
- Trial participants with synchronous or multiple primary malignancies.
- Residual toxicity ≥ Grade 2 resulting from prior anti-tumor therapy.
- Symptomatic central nervous system (CNS) metastases and/or leptomeningeal metastases.
- History of severe cardiovascular disease.
- Cerebrovascular accident, pulmonary embolism, or deep vein thrombosis occurring within 3 months prior to the first dose of the investigational drug; thrombosis associated with implanted venous ports or catheters; or superficial vein thrombosis, except for patients with stable thrombosis after standard anticoagulation therapy. Prophylactic use of low-dose low-molecular-weight heparin is permitted.
- Clinically symptomatic moderate or larger volume pleural, ascitic, or pelvic effusions requiring clinical intervention, or clinically symptomatic pericardial effusion.
- History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the investigational drug that has not healed following surgical treatment; risk of bowel obstruction or bowel perforation; extensive bowel resection; poorly controlled Crohn's disease, ulcerative colitis, or other gastrointestinal autoimmune or inflammatory diseases; presence of pyloric obstruction and/or persistent recurrent vomiting.
- Active chronic hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
- Hypersensitivity to any component or excipient of MRG007, or known ≥ Grade 3 hypersensitivity to other prior anti-CDH17 antibodies or other monoclonal antibodies.
- Body weight loss ≥ 10% during the screening period. Any severe and/or uncontrolled systemic disease that, in the opinion of the investigator and the sponsor, renders the participant unsuitable for participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2026
First Posted
July 30, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share