New hope for stubborn gut cancers? early trial launches
NCT ID NCT07216560
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This early-phase trial is testing an experimental drug called 7MW4911 in 200 people with advanced colorectal or other gastrointestinal cancers that have progressed after standard treatments. The main goals are to find a safe dose and to see if the drug can shrink tumors. It is the first time this drug is being studied in humans in the US.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 7MW4911 (an experimental drug)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced gastrointestinal cancers that have stopped responding to standard therapies.
- What could go wrong
- This is a very early first-in-human study, so the drug may not work or could cause unexpected side effects. The results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Hematology Oncology Associates of the Treasure Coast
RECRUITINGPort Saint Lucie, Florida, 34952, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10021, United States
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START
RECRUITINGLong Island City, New York, 11042, United States
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START Moutain Region
RECRUITINGWest Valley City, Utah, 84119, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug combo shrink Hard-to-Treat colorectal tumors?
- New drug combo aims to outperform standard therapy for advanced colorectal cancer
- New cocktail of drugs aims to tackle tough colorectal cancer
- Cottonseed compound plus immunotherapy takes on tough colorectal cancer
- New drug cocktail hopes to tackle advanced colon cancer
- Massive cancer registry aims to unlock better GI cancer care