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

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of 7MW4911 in Patients With Advanced Solid Tumors

This trial will test whether the experimental drug 7MW4911 is safe and shows anti-tumor activity in Chinese adults with advanced solid tumors who have progressed after prior treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07265622 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18–75 with confirmed advanced solid tumors, ECOG 0–1, measurable disease per RECIST v1.1, prior progression on standard therapy, and adequate organ function who can provide tumor tissue.

Not a fit: Patients with poor performance status (ECOG >1), life expectancy under three months, active untreated symptomatic brain metastases, uncontrolled cardiovascular or severe respiratory disease, or autoimmune conditions requiring systemic treatment are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, 7MW4911 could provide a new treatment option that shrinks tumors or stabilizes disease for patients with advanced solid tumors who have exhausted approved therapies.

How similar studies have performed: As a first-in-human agent there is limited human data on 7MW4911, and while some early-phase biologics and targeted agents have produced responses in select tumor types, overall results have been mixed and uncertain.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lei Cong

Conditions Solid Tumors