RecruitingPhase 1Phase 2NCT07466160

A Phase Ib/II Study of 7MW3711 Combined With JS207 in 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


Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

280 participants

Start Date

Feb 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Life expectancy of at least 3 months as assessed by the Investigator.
  • 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.
  • Measurable or evaluable disease by RECIST v1.1.
  • Have adequate hematopoietic, renal and hepatic functions.
  • Men or women willing to use adequate contraceptive measures throughout the study.

Exclusion Criteria10

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

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Interventions

DRUG7MW3711

7MW3711 will be administered as IV infusion.

DRUGJS207

JS207 will be administered as IV infusion.

DRUGCisplatin

Cisplatin will be administered as IV infusion.

DRUGCarboplatin

Carboplatin will be administered as IV infusion.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT07466160


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