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

NCT07466160 | Recruiting Phase 1

• 1 other identifier: 7MW3711-CP202
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Keywords

NSCLC; SCLC

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events (AEs)

  AEs are assessed based on NCI CTCAE v6.0.

  Up to approximately 2 years

• Maximum tolerate dose（MTD)

  MTD of 7MW3711

  Up to approximately 2 years

• Recommended Expansion Dose (RED)

  RED of 7MW3711

  Up to approximately 2 years

Secondary Outcomes (9)

• Area Under the Concentration-time Curve (AUC)

  Up to approximately 2 years

• Maximum concentration (Cmax)

  Up to approximately 2 years

• Plasma clearance (CL)

  Up to approximately 2 years

• Half-life (t1/2)

  Up to approximately 2 years

• Time to peak drug concentration (Tmax)

  Up to approximately 2 years

Study Arms (2)

Phase 1b: Safety run-in

EXPERIMENTAL

Multiple dose levels of 7MW3711 will be explored in combination with JS207 with or without Chemotheray administered intravenously (IV) at a fixed dose as specified in the protocol.

Drug: 7MW3711; Drug: JS207; Drug: Cisplatin; Drug: Carboplatin

Phase 2: Dose expansion

EXPERIMENTAL

7MW3711 will be administered at the selected RDE in combination with JS207 with or without Chemotheray administered IV at a fixed dose as specified in the protocol.

Drug: 7MW3711; Drug: JS207; Drug: Cisplatin; Drug: Carboplatin

Interventions

7MW3711 DRUG

7MW3711 will be administered as IV infusion.

Phase 1b: Safety run-in; Phase 2: Dose expansion

JS207 DRUG

JS207 will be administered as IV infusion.

Phase 1b: Safety run-in; Phase 2: Dose expansion

Cisplatin DRUG

Cisplatin will be administered as IV infusion.

Phase 1b: Safety run-in; Phase 2: Dose expansion

Carboplatin DRUG

Carboplatin will be administered as IV infusion.

Phase 1b: Safety run-in; Phase 2: Dose expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200043, China

RECRUITING

MeSH Terms

Interventions

Cisplatin; Carboplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

Shun Lu, Doctor

CONTACT

021-22200000; shun_lu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)