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.

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

Primary outcomes

• Incidence and severity of adverse events (AEs) [Up to approximately 2 years]: AEs are assessed based on NCI CTCAE v6.0.
• Maximum tolerate dose（MTD) [Up to approximately 2 years]: MTD of 7MW3711
• Recommended Expansion Dose (RED) [Up to approximately 2 years]: RED of 7MW3711

Secondary outcomes

• Area Under the Concentration-time Curve (AUC) [Up to approximately 2 years]: AUC of 7MW3711
• Maximum concentration (Cmax) [Up to approximately 2 years]: Cmax of 7MW3711
• Plasma clearance (CL) [Up to approximately 2 years]: CL of 7MW3711
• Half-life (t1/2) [Up to approximately 2 years]: t1/2 of 7MW3711
• Time to peak drug concentration (Tmax) [Up to approximately 2 years]: Tmax of 7MW3711
• Investigator-assessed progression-free survival (PFS) [Up to approximately 2 years]: PFS defined as the time interval from the first study drug administration to the first documented PD or death due to any cause, whichever occurs first.
• Overall survival (OS) [Up to approximately 2 years]: OS defined as the time interval from the first study drug administration to death due to any cause.
• Investigator-assessed disease control rate (DCR) [Up to approximately 2 years]: DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
• Immunogenicity [Up to approximately 2 years]: Incidence and rates of ADA

Sex: All, ages: 18 Years to 75 Years

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.