GI CancersPhase 1/2NCT07216560
First-in-human Study of 7MW4911 in GI Cancer
A Phase 1/2 study testing 7MW4911 in people with GI Cancers, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 6 sites in United States.
Trial summary
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Cancers
- What is being tested?
- 7MW4911
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Jan 2026to Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Provision of archival tumor tissue or fresh biopsy.
- Adequte hematologic funciton, liver function and renal function.
- Comply with contraceptive requirements
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wenhui Zhang contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ashley O'Meara, 866-493-1612, ALOMEARA@mgh.harvard.edu
- Recruiting
START
Long Island City, New York, 11042
Sadia Morium, 363-207-5160, sadia.morium@startresearch.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Cyrstal Ramos, ramosc3@mskcc.org
Guilllermo Argiles Martinez, MD
- Recruiting
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Kerlande Romeus, 772-408-5157, kromeus@hemoncfl.com
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Isabel Blanco, 206-606-6658, iblanco@fredhutch.org
- Recruiting
START Moutain Region
West Valley City, Utah, 84119
Raynard Bello, 801-907-4750, research@utahcancer.com
+1(801)9074750
About this study
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
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
- Conditions
- GI Cancers
- Being tested
- 7MW4911
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7MW4911Drug
study drug
| Study group | Role | What they receive |
|---|---|---|
| 7MW4911 | Experimental | Not described Receives: Drug: 7MW4911 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and rates of adverse events
To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors
Measured: Up to approximately 2 years
MTD, RED, and RP2D
To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)
Measured: Up to approximately 2 years
Secondary outcomes (7)
Tmax of 7MW4911
time to maximum concentration of 7MW4911 in blood
Measured: up to 3 months
Cmax of 7MW4911
maximum concentration of 7MW4911 in bloood
Measured: up to 3 months
Half life of 7MW4911
time to decrease of 7MW4911 concentration by 50% in blood
Measured: up to 3 months
Area under the curve of 7MW4911
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
Measured: up to 3 months
Objective response rate
proportion of patients whose turmor response meet the criteria of complete response or partial response
Measured: Up to approximately 2 years
Progression-free survival
Duration in months from enrollment to first disease progression
Measured: up to approximately 2 years
Immunogenicity of 7MW4911
Incidence and rates of ADA
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start13 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216560
- Sponsor's protocol ID
- 7MW4911-CP101
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No