First human use of 7MW4911 in gastrointestinal cancer

A Phase I/II Study of 7MW4911 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Advanced Colorectal Cancer and Other Advanced Gastrointestinal Tumors

This study will test a new drug called 7MW4911 in adults with advanced or metastatic gastrointestinal cancers that have progressed after standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Locations: 5 sites (Port Saint Lucie, Florida and 4 other locations)
• Trial ID: NCT07216560 on ClinicalTrials.gov

What this trial studies

This first-in-human, phase 1/2 interventional study will enroll U.S. adults with advanced or metastatic gastrointestinal cancers who have progressed after standard of care. Phase 1 will focus on safety, tolerability, and identifying a recommended dose, while phase 2 will explore preliminary anti-tumor activity. Eligible patients must have ECOG 0-1, measurable disease by RECIST v1.1, provide tumor tissue, and meet laboratory and organ function requirements. Key exclusions include untreated symptomatic CNS metastases, active autoimmune disease requiring systemic therapy, recent other malignancies, and uncontrolled cardiovascular or severe respiratory disease.

Who should consider this trial

Good fit: Adults (18+) with advanced or metastatic gastrointestinal cancer that progressed after standard treatments, ECOG 0-1, measurable disease, and adequate organ and marrow function are the intended participants.

Not a fit: Patients with active untreated CNS metastases, recent other malignancies, effusions requiring frequent drainage, active autoimmune disease needing systemic treatment, or uncontrolled cardiac/respiratory conditions are excluded and unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, 7MW4911 could provide a new treatment option that shrinks tumors or slows disease in patients with advanced GI cancers who have exhausted standard therapies.

How similar studies have performed: This is a first-in-human trial for 7MW4911 so there are no prior clinical results for this agent, though related targeted or biologic approaches have shown activity in some GI cancers in other studies.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 and above
2. ECOG 0-1
3. Life expectancy ≥ 3 months
4. Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.
5. Disease progression after the most recent treatment regimen
6. At least one measurable lesion according to RECIST v1.1
7. Provision of archival tumor tissue or fresh biopsy.
8. Adequte hematologic funciton, liver function and renal function.
9. Comply with contraceptive requirements

Exclusion Criteria:

1. Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
2. Active, untreated or symptomatic CNS metastasis
3. Effusions that require frequent drainage
4. Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
5. Severe respiratory disease that required hospitalization in the last 28 days.
6. Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration
7. Poorly controlled blood glucose with fasting blood glucose above 10mmol/L
8. Recipient of allogeneic stem cell transplant or organ transplant
9. Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
10. Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
11. Prohibited treatment and treatment that requires washout period

    1. Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy.
    2. Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration.
    3. Major surgeries within 28 days prior to study drug administration
    4. Investigational therapy within 28 days prior to study drug administration
    5. Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed.
    6. Use of strong CYP3A4 inhibitor or inducer
12. Known hypersensitivity to 7MW4911 or components of the formulation
13. Abuse of narcotic or psychoactive drugs
14. Pregnant or breastfeeding women
15. Other circumstances or conditions where the investigator judges to be unsuitable for study.

Where this trial is running

Port Saint Lucie, Florida and 4 other locations

• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Start — Long Island City, New York, United States (Recruiting)
• START Moutain Region — West Valley City, Utah, United States (Recruiting)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Shaona Cai

Conditions GI Cancers