> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ib-ii-study-of-7mw3711-combined-with-js207-in-77866a87-3595-4120-a562-418bf7db9a3d > Record changed: 2026-11-04 # A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors NCT07466160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) Participants 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) Lead sponsor Mabwell (Shanghai) Bioscience Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) Start date 2026-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Title and summary **Summary** This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Short title** A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Dates **Completion date** 2029-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **First posted** 2026-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Registry last updated** 2026-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Primary completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Start date** 2026-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Size and sites **Participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Planned participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Lead sponsor** Mabwell (Shanghai) Bioscience Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Identifiers **Registry ID** NCT07466160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **ClinicalTrials.gov ID** NCT07466160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Outcomes ### Primary outcomes 1. Incidence and severity of adverse events (AEs) Timeframe: Up to approximately 2 years AEs are assessed based on NCI CTCAE v6.0. 2. Maximum tolerate doseļ¼ˆMTD) Timeframe: Up to approximately 2 years MTD of 7MW3711 3. Recommended Expansion Dose (RED) Timeframe: Up to approximately 2 years RED of 7MW3711 ### Secondary outcomes 1. Area Under the Concentration-time Curve (AUC) Timeframe: Up to approximately 2 years AUC of 7MW3711 2. Maximum concentration (Cmax) Timeframe: Up to approximately 2 years Cmax of 7MW3711 3. Plasma clearance (CL) Timeframe: Up to approximately 2 years CL of 7MW3711 4. Half-life (t1/2) Timeframe: Up to approximately 2 years t1/2 of 7MW3711 5. Time to peak drug concentration (Tmax) Timeframe: Up to approximately 2 years Tmax of 7MW3711 6. Investigator-assessed progression-free survival (PFS) Timeframe: 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. 7. Overall survival (OS) Timeframe: Up to approximately 2 years OS defined as the time interval from the first study drug administration to death due to any cause. 8. Investigator-assessed disease control rate (DCR) Timeframe: Up to approximately 2 years DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD). 9. Immunogenicity Timeframe: Up to approximately 2 years Incidence and rates of ADA Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Sites - Shanghai Chest HospitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07466160) ## Related records ### Drugs (2) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) ### Lead sponsors (1) - [Mabwell (Shanghai) Bioscience Co., Ltd.](https://trialight.com/data/company/mabwell-shanghai-bioscience-co-ltd-94540514-5802-40a0-b2fa-222ee3c6bfeb.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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