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

Not Applicable

Not yet recruiting

• Conditions: GI Cancers
• Interventions: Drug: 7MW4911

• Registration Number: NCT07216560
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-24
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-10
• Last Update Submitted: 2025-10-10
• Study First Posted: 2025-10-14
• Last Update Posted: 2025-10-14
• Study Start: 2025-11-01
• Primary Completion: 2027-07
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
7MW4911	7MW4911	-

Primary Outcome Measures

Name	Time	Method
Incidence and rates of adverse events	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	Up to approximately 2 years	To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)

Secondary Outcome Measures

Name	Time	Method
Tmax of 7MW4911	up to 3 months	time to maximum concentration of 7MW4911 in blood
Cmax of 7MW4911	up to 3 months	maximum concentration of 7MW4911 in bloood
Half life of 7MW4911	up to 3 months	time to decrease of 7MW4911 concentration by 50% in blood
Area under the curve of 7MW4911	up to 3 months	Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
Objective response rate	Up to approximately 2 years	proportion of patients whose turmor response meet the criteria of complete response or partial response
Progression-free survival	up to approximately 2 years	Duration in months from enrollment to first disease progression
Immunogenicity of 7MW4911	Up to approximately 2 years	Incidence and rates of ADA