RightFit
RecruitingPhase 1 / Phase 2

First-in-human Study of 7MW4911 in GI 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests 7MW4911 in people for the first time in the United States. It looks at early signs of safety and how well it works in adults with advanced digestive system cancers that have worsened after standard treatment.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You can do most daily tasks, with little or no limit on activity.
  • You are expected to live at least 3 months.
  • Your digestive system cancer is advanced or has spread, and it has worsened after standard care and your most recent treatment.
  • You have at least one tumor that can be measured using the study's rules.
  • You can provide a stored tumor sample or a new sample taken by biopsy.
  • Your blood, liver, and kidney test results meet the study's requirements.
  • You agree to follow the study's birth control rules.

Who can't join

  • You had another cancer within the past 3 years, except an early cancer that stayed where it started and was adequately treated; or you have active, untreated, or symptom-causing cancer spread to the brain or spinal cord.
  • You have fluid buildup that needs frequent draining, or an active disease in which your immune system attacks your body. Exceptions include type 1 diabetes, low thyroid function, and other such diseases that do not need whole-body treatment.
  • You had severe breathing disease needing a hospital stay within 28 days, or serious, uncontrolled heart or blood vessel disease or events within 6 months before the study drug. You also cannot join if your blood sugar is poorly controlled and is above 10 mmol/L after fasting.
  • You received donor stem cells or an organ transplant; have active HIV, hepatitis B, or hepatitis C; or had an infection needing whole-body treatment through a vein within 14 days before the study drug.
  • Side effects from past cancer treatment have not improved to mild or gone away, except hair loss or hormone gland problems; or you have a known allergy to 7MW4911 or its ingredients.
  • You previously received a drug-antibody treatment carrying a Topo-I drug or a treatment targeting CDH17. Other cancer drugs require a waiting period of 5 half-lives—the time for drug levels to fall by half—or 21 days. Major surgery or experimental treatment within 28 days also excludes you.
  • You received whole-body immune-suppressing drugs within 28 days before the first dose, except allowed steroid replacement doses or steroids used on the skin; or you use drugs that strongly change how the liver enzyme CYP3A4 works.
  • You misuse narcotics or mind-altering drugs, are pregnant or breastfeeding, or have another condition that the study doctor believes makes the study unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (6)

FL

MA

NY

UT

WA