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Clinical Trials in China / NCT07265622
Recruiting Phase 1/2

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

NCT07265622 · tracked via the Priya Life Science China tracker
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
Phase
Phase 1/2
Started
2025-11-12
Last updated
2025-12-29

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

7MW4911

7MW4911: 7MW4911 for IV infusion of various dose strengths administered

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

More Mabwell (Shanghai) Bioscience Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07265622 on ClinicalTrials.gov ↗ ← All trials in China