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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Carboplatin; Drug: Cisplatin; Drug: 7MW3711; Drug: JS207

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.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shun Lu, Doctor; Phone Number: 3121 021-22200000; Email: shun_lu@hotmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200043
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Shun Lu, Doctor; Phone Number: 3121 021-22200000; Email: shun_lu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1b: Safety run-in; 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: Carboplatin; Carboplatin will be administered as IV infusion.; Drug: Cisplatin; Cisplatin will be administered as IV infusion.; Drug: 7MW3711; 7MW3711 will be administered as IV infusion.; Drug: JS207; JS207 will be administered as IV infusion.
Experimental: Phase 2: Dose expansion; 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: Carboplatin; Carboplatin will be administered as IV infusion.; Drug: Cisplatin; Cisplatin will be administered as IV infusion.; Drug: 7MW3711; 7MW3711 will be administered as IV infusion.; Drug: JS207; JS207 will be administered as IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; SCLC
• Additional Relevant MeSH Terms: Organic Chemicals; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Platinum Compounds; Carboplatin; Cisplatin
• Other Study ID Numbers: 7MW3711-CP202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No