First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors

NCT07265622 | Recruiting Phase 1

• 1 other identifier: 7MW4911-CP102
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.

Conditions

Solid Tumors

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

• Maximum tolerated dose (MTD), recommended expansion dose (RED) and the recommended phase II dose (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)

• Objective response rate

  Up to approximately 2 years

• Progression-free survival

  Up to approximately 2 years

• Immunogenicity

  Up to approximately 2 years

• Tmax

  Up to 3 months

• Cmax

  Up to 3 months

Study Arms (1)

7MW4911

EXPERIMENTAL

Drug: 7MW4911

Interventions

7MW4911 DRUG

7MW4911 for IV infusion of various dose strengths administered

7MW4911

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18\~75.
• ECOG 0-1.
• Life expectancy ≥ 3 months.
• Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
• 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 10 mmol/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: (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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Lei Cong

CONTACT

+86-18756936922; lei.cong@mabwell.com

Study Design

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

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 5, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CN (1)