First human use of 7MW4911 in gastrointestinal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Memorial Sloan Kettering Cancer Center
  New York, 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: Matthew Brobeck
• Email: matthew.brobeck@mabwell.com
• Phone: (801) 201.4911

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Digital app to support oncologist‑initiated genetic testing

  This project tests a digital app (GA‑Mainstream) to help oncologists offer germline genetic testing to adults with breast, prostate, colon, or other GI cancers.

  Recruiting at 2 sites Unity Health Toronto · Toronto, Ontario and 1 other locations · NCT07387263

• Collecting blood and tissue samples from patients with gastrointestinal cancer

  This study is collecting blood and tissue samples from people with gastrointestinal cancers to see how their immune system and gut bacteria affect the disease and to help improve future treatments.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT01313442

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.