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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
Show all 21Show fewer
- 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.
Eric Li 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.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- 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
- Oct 2026
- First submitted
- 24 Sep 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07216560
- Acronym / sponsor ID
- 7MW4911-CP101
- Conditions
- GI Cancers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7MW4911 | Experimental | Drug: 7MW4911 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7MW4911study drug | Drug | 7MW4911 |
Primary outcome
Incidence and rates of adverse events
Time frame: Up to approximately 2 years
To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors
MTD, RED, and RP2D
Time frame: Up to approximately 2 years
To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for GI Cancers
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
Gastrointestinal Cancers
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1/2
Immunotherapy Treating GI Cancer
Cancer
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Li contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Brobeck ((801) 201.4911, matthew.brobeck@mabwell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and rates of adverse events (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.