A Study of RC88 Combined With JS001 for Advanced Solid Tumours

Study Overview
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Brief Summary
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This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with JS001 in advancedsolid tumours

Official Title
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An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC888 Combined With JS001in AdvancedSolid Tumours

Conditions
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Advanced Solid Tumours

Intervention / Treatment
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* Drug: RC88
* Drug: JS001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RC88+JS001<br>RC88+JS001 Arm | Drug: RC88<br>* 1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks<br>Drug: JS001<br>* JS001 240mg by intravenous (IV) infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RP2D | Incidence of DLT (dose limiting toxicity) of RC88 combined with JS001 | 28 days after first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) | 24 months | 
| Maximum Concentration (Cmax) of RC88 | Dose Escalation and Expansion Part | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours | 
| Progression Free Survival (PFS) | Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. | 24 months |