A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer
NCT07737600
Phase
Phase 1/Phase 2
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Lepu Biopharma Co., Ltd.
Start date
2026-08-01
Number of sites
- 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.
- Short title
- A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer
- Official title
- Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of MRG007 Combination Therapy in Patients With Advanced Colorectal Cancer
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2029-12-01
- First posted
- 2026-07-30
- Registry last updated
- 2026-08-04
- Primary completion date
- 2028-12-01
- Start date
- 2026-08-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Lepu Biopharma Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07737600
- ClinicalTrials.gov ID
- NCT07737600
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Dose Limiting Toxicity (DLT)
Timeframe: From the first dose to 30 days after the last dose
Serious Adverse Events (SAEs)
Timeframe: From the first dose to 30 days after the last dose
Adverse Event (AE)
Timeframe: From the first dose to 30 days after the last dose
Recommended Phase 2 Dose(RP2D) and/or Maximum Tolerated Dose (MTD)
Timeframe: From the first dose to 30 days after the last dose
Objective Response Rate (ORR)
Timeframe: Assessments will be performed every 6 weeks (± 7 days) following the first dose.
Serum Concentration
Timeframe: up to 2 years
Serum Concentration of ADC, TAb, free payload will be measured.
Anti-Drug Antibody (ADA)
Timeframe: up to 2 years
The proportion of patients with positive ADA results.
Neutralizing antibody (NAb)
Timeframe: up to 2 years
The proportion of patients with positive NAb results.
Duration of Response (DOR)
Timeframe: Through study completion, an average 2 years
Disease Control Rate (DCR)
Timeframe: Through study completion, an average 2 years
Progression-Free Survival (PFS)
Timeframe: Through study completion, an average 2 years
Overall Survival (OS)
Timeframe: Through study completion, an average 2 years
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
Sources for eligibility
- Peking University cancer HospitalBeijing, China
Sources for sites
Related records
Drugs (5)
Lead sponsors (1)
Conditions (1)
- Colorectal neoplasm Primary condition