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

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of 7MW4911 in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: 7MW4911

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

Contacts and Locations

• Study Contact: Name: Lei Cong; Phone Number: +86-18756936922; Email: lei.cong@mabwell.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xianjun Yu; Phone Number: +86-021-64175590; Email: yuxianjun@fudanpci.org

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Aged 18~75.
2. ECOG 0-1.
3. Life expectancy ≥ 3 months.
4. Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
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 10 mmol/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: N/A
• 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; 7MW4911 for IV infusion of various dose strengths administered

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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 treatment to disease progression or death from any cause, whichever occurs first.	Up to approximately 2 years
Immunogenicity	Incidence and rates of ADA	Up to approximately 2 years
Tmax	Time to maximum concentration of 7MW4911 in blood	Up to 3 months
Cmax	Maximum concentration of 7MW4911 in bloood	Up to 3 months
t1/2	Time to decrease of 7MW4911 concentration by 50% in blood	Up to 3 months
Area under the curve	Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)	Up to 3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 7MW4911-CP102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No