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Recruiting NCT07466160

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

Phase I / Phase II Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 7MW3711, JS207, Cisplatin, Carboplatin.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Drug 7MW3711
    7MW3711 will be administered as IV infusion.
  • Drug JS207
    JS207 will be administered as IV infusion.
  • Drug Cisplatin
    Cisplatin will be administered as IV infusion.
  • Drug Carboplatin
    Carboplatin will be administered as IV infusion.

Primary outcome measures

  • Incidence and severity of adverse events (AEs) [Time frame: Up to approximately 2 years]
  • Maximum tolerate dose（MTD) [Time frame: Up to approximately 2 years]
  • Recommended Expansion Dose (RED) [Time frame: Up to approximately 2 years]
Secondary outcome measures (9)
  • Area Under the Concentration-time Curve (AUC) [Time frame: Up to approximately 2 years]
  • Maximum concentration (Cmax) [Time frame: Up to approximately 2 years]
  • Plasma clearance (CL) [Time frame: Up to approximately 2 years]
  • Half-life (t1/2) [Time frame: Up to approximately 2 years]
  • Time to peak drug concentration (Tmax) [Time frame: Up to approximately 2 years]
  • Investigator-assessed progression-free survival (PFS) [Time frame: Up to approximately 2 years]
  • Overall survival (OS) [Time frame: Up to approximately 2 years]
  • Investigator-assessed disease control rate (DCR) [Time frame: Up to approximately 2 years]
  • Immunogenicity [Time frame: Up to approximately 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT07466160 · 7MW3711-CP202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗