First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors
NCT ID: NCT07265622
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2025-11-12
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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7MW4911
7MW4911
7MW4911 for IV infusion of various dose strengths administered
Interventions
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7MW4911
7MW4911 for IV infusion of various dose strengths administered
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Mabwell (Shanghai) Bioscience Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xianjun Yu
Role: primary
Other Identifiers
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7MW4911-CP102
Identifier Type: -
Identifier Source: org_study_id