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

Study Identifier:
7MW4911-CP101
CT.gov Identifier:
NCT07216560
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate the safety, pharmacokinetics, and efficacy of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors. This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Gastric
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: 7MW4911
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Recruiting
    Condition(s) Treated at Site
    Gastric
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Gastric