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

NCT07466160
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
280
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Lead sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
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Start date
2026-02-11
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Number of sites
1
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Summary
This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.
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Short title
A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2029-12-31
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First posted
2026-03-12
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Registry last updated
2026-03-12
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Primary completion date
2027-12-31
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Start date
2026-02-11
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Participants
280
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Participant count basis
Estimated
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Planned participants
280
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07466160
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ClinicalTrials.gov ID
NCT07466160
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  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

  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
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  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.

  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
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  • Shanghai Chest HospitalShanghai, ChinaRecruiting
Sources for sites
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Related records

Drugs (2)

Lead sponsors (1)