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

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 Overview

• Status: Recruiting
• Conditions: GI Cancers
• Intervention / Treatment: Drug: 7MW4911

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shaona Cai; Phone Number: +86-021-58332260; Email: shaona.cai@mabwell.com
• Study Contact Backup: Name: Wenhui Zhang; Email: wenhui.zhang@mabwell.com

Study Locations

• United States
  • Florida
    • Port Saint Lucie, Florida, United States, 34952
      • Recruiting
      • Hematology Oncology Associates of the Treasure Coast
      • Contact: Kerlande Romeus; Phone Number: 772-408-5157; Email: kromeus@hemoncfl.com
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Ashley O'Meara; Phone Number: 866-493-1612; Email: ALOMEARA@mgh.harvard.edu
  • New York
    • Long Island City, New York, United States, 11042
      • Recruiting
      • START
      • Contact: Sadia Morium; Phone Number: 363-207-5160; Email: sadia.morium@startresearch.com
  • Utah
    • West Valley City, Utah, United States, 84119
      • Recruiting
      • START Moutain Region
      • Contact: Phone Number: +1(801)9074750
      • Contact: Raynard Bello; Phone Number: 801-907-4750; Email: research@utahcancer.com
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center
      • Contact: Isabel Blanco; Phone Number: 206-606-6658; Email: iblanco@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7MW4911	Drug: 7MW4911; study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax of 7MW4911	time to maximum concentration of 7MW4911 in blood	up to 3 months
Cmax of 7MW4911	maximum concentration of 7MW4911 in bloood	up to 3 months
Half life of 7MW4911	time to decrease of 7MW4911 concentration by 50% in blood	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)	up to 3 months
Objective response rate	proportion of patients whose turmor response meet the criteria of complete response or partial response	Up to approximately 2 years
Progression-free survival	Duration in months from enrollment to first disease progression	up to approximately 2 years
Immunogenicity of 7MW4911	Incidence and rates of ADA	Up to approximately 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker for efficacy	To explore the relationship between the expression of CDH17 in tumor tissues and other biomarkers and the efficacy and safety of 7MW4911 in patients with advanced colorectal cancer and selected gastrointestinal tumor types	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: October 10, 2025
• First Posted (Actual): October 14, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 7MW4911-CP101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No