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Recruiting NCT07216560

First-in-human Study of 7MW4911 in GI Cancer

Phase I / Phase II Interventional GI Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 7MW4911.
Who it may be relevant to
Registry conditions: GI Cancers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.

Interventions

  • Drug 7MW4911
    study drug

Primary outcome measures

  • Incidence and rates of adverse events [Time frame: Up to approximately 2 years]
  • MTD, RED, and RP2D [Time frame: Up to approximately 2 years]
Secondary outcome measures (7)
  • Tmax of 7MW4911 [Time frame: up to 3 months]
  • Cmax of 7MW4911 [Time frame: up to 3 months]
  • Half life of 7MW4911 [Time frame: up to 3 months]
  • Area under the curve of 7MW4911 [Time frame: up to 3 months]
  • Objective response rate [Time frame: Up to approximately 2 years]
  • Progression-free survival [Time frame: up to approximately 2 years]
  • Immunogenicity of 7MW4911 [Time frame: Up to approximately 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie
  • Massachusetts General Hospital — Boston
  • START — Long Island City
  • START Moutain Region — West Valley City
  • Fred Hutchinson Cancer Center — Seattle

Identifiers

NCT: NCT07216560 · 7MW4911-CP101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗