NCT07265622 First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors
| NCT ID | NCT07265622 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2025-11-12 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07265622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07265622 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07265622 currently recruiting?
Yes, NCT07265622 is actively recruiting participants. Contact the research team at lei.cong@mabwell.com for enrollment information.
Where is the NCT07265622 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07265622 clinical trial?
NCT07265622 is sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. The trial plans to enroll 200 participants.