First-in-human Study of 7MW4911 in GI Cancer

NCT07216560 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 7MW4911-CP101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

GI Cancers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Tmax of 7MW4911

  up to 3 months

• Cmax of 7MW4911

  up to 3 months

• Half life of 7MW4911

  up to 3 months

• Area under the curve of 7MW4911

  up to 3 months

• Objective response rate

  Up to approximately 2 years

Other Outcomes (1)

• Biomarker for efficacy

  Up to approximately 2 years

Study Arms (1)

7MW4911

EXPERIMENTAL

Drug: 7MW4911

Interventions

7MW4911 DRUG

study drug

7MW4911

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Provision of archival tumor tissue or fresh biopsy.
• Adequte hematologic funciton, liver function and renal function.
• Comply with contraceptive requirements

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (5)

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

START

Long Island City, New York, 11042, United States

RECRUITING

START Moutain Region

West Valley City, Utah, 84119, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Central Study Contacts

Shaona Cai

CONTACT

+86-021-58332260; shaona.cai@mabwell.com

Wenhui Zhang

CONTACT

wenhui.zhang@mabwell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 14, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)