Status:
NOT_YET_RECRUITING
First-in-human Study of 7MW4911 in GI Cancer
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
GI Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
Eligibility Criteria
Inclusion
- Aged 18 and above
- ECOG 0-1
- Life expectancy ≥ 3 months
- Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.
- Disease progression after the most recent treatment regimen
- At least one measurable lesion according to RECIST v1.1
- Provision of archival tumor tissue or fresh biopsy.
- Adequte hematologic funciton, liver function and renal function.
- Comply with contraceptive requirements
Exclusion
- Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
- Active, untreated or symptomatic CNS metastasis
- Effusions that require frequent drainage
- Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
- Severe respiratory disease that required hospitalization in the last 28 days.
- Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration
- Poorly controlled blood glucose with fasting blood glucose above 10mmol/L
- Recipient of allogeneic stem cell transplant or organ transplant
- Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
- Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
- Prohibited treatment and treatment that requires washout period
- Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy.
- Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration.
- Major surgeries within 28 days prior to study drug administration
- Investigational therapy within 28 days prior to study drug administration
- Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed.
- Use of strong CYP3A4 inhibitor or inducer
- Known hypersensitivity to 7MW4911 or components of the formulation
- Abuse of narcotic or psychoactive drugs
- Pregnant or breastfeeding women
- Other circumstances or conditions where the investigator judges to be unsuitable for study.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07216560
Start Date
November 1 2025
End Date
December 1 2028
Last Update
October 14 2025
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