First-in-human use of 7MW4911 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human phase 1/2 trial enrolls Chinese adults with pathologically confirmed advanced solid tumors that have progressed after standard therapy. It begins with dose-escalation to define safety, tolerability, and a recommended phase 2 dose, followed by expansion cohorts to look for preliminary anti-tumor activity using RECIST v1.1 measurable lesions. Participants must have ECOG performance status 0–1, adequate organ and hematologic function, and provide archival or fresh tumor tissue, and they will be monitored with labs, imaging, and adverse-event assessments. Key exclusions include recent other malignancies, untreated symptomatic brain metastases, frequent effusions, active autoimmune disease requiring systemic therapy, and significant uncontrolled cardiovascular or recent severe respiratory disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lei Cong
• Email: lei.cong@mabwell.com
• Phone: +86-18756936922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.