7MW3711 plus JS207 for advanced solid tumors

A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 With or Without Chemotheray in Patients With Advanced Solid Tumors

This trial tests whether combining the experimental drugs 7MW3711 and JS207, with or without platinum chemotherapy, can help adults with advanced or metastatic solid tumors that have progressed after standard treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07466160 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase Ib/II study gives escalating doses of 7MW3711 with JS207, with or without cisplatin or carboplatin, to evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity. Phase Ib uses dose-escalation to identify recommended doses and characterize side effects, while Phase II expands selected tumor cohorts to measure response by RECIST v1.1. Eligible patients must have measurable disease, ECOG 0–1, adequate organ function, and prior progression on or intolerance to standard therapies. Patients receive study drugs per protocol with regular imaging and laboratory monitoring for efficacy and adverse events.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed locally advanced or metastatic solid tumors, measurable disease, ECOG 0–1, adequate organ function, and progression after or intolerance of standard therapies are the intended participants.

Not a fit: Patients with active or untreated central nervous system metastases, recent other malignancies within three years, or inadequate hematologic, renal, or hepatic function are unlikely to qualify and may not benefit from this investigational regimen.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that shrinks tumors or slows disease progression for some patients with advanced solid tumors.

How similar studies have performed: Some investigational agent plus platinum combinations have shown activity in particular solid tumors, but 7MW3711 and JS207 are novel agents with limited prior clinical data and remain unproven.

Eligibility criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
2. Life expectancy of at least 3 months as assessed by the Investigator.
3. Phase 1b: Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies. Phase 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors.
4. Measurable or evaluable disease by RECIST v1.1.
5. Have adequate hematopoietic, renal and hepatic functions.
6. Men or women willing to use adequate contraceptive measures throughout the study.

Exclusion Criteria:

1. Have other prior malignancies within 3 years before the first administration.
2. Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
3. Have significant, uncontrolled, or active cardiovascular disease.
4. Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
5. Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V6.0.
6. Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
7. Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
8. Prior treatment with B7-H3 targeted agents.
9. Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
10. Pregnant, or nursing females.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Shun Lu, Doctor

Conditions: Solid Tumor, NSCLC, SCLC