NCT05804526RecruitingPhase 1
An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC88 Combined With Sintilimab in AdvancedSolid Tumours
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- RemeGen Co., Ltd.
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- RP2D
Study Overview
Brief Summary
This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary agreement to provide written informed consen
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Predicted survival ≥ 12 weeks
- •Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma;
- •Adequate organ function required
- •Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
Exclusion Criteria
- •Cancer metastases in the brain
- •Active infection or past hepatitis B or C infection
- •Major surgery less than 1 month before the start of the study
- •Uncontrolled heart disease
- •History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds
Arms & Interventions
RC88+Sintilimab Injection
Experimental
RC88+Sintilimab Injection Arm
Intervention: RC88 (Drug)
RC88+Sintilimab Injection
Experimental
RC88+Sintilimab Injection Arm
Intervention: Sintilimab Injection (Drug)
Outcomes
Primary Outcomes
RP2D
Time Frame: 28 days after first treatment
Incidence of DLT (dose limiting toxicity) of RC88 combined with Sintilimab
Secondary Outcomes
- ORR(24 months)
- Maximum Concentration (Cmax) of RC88(pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours)
- Progression Free Survival (PFS)(24 months)
Investigators
Study Sites (1)
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