7MW3711 plus JS207 for 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Shun Lu, Doctor
• Email: shun_lu@hotmail.com
• Phone: 021-22200000

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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.