A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

Study Overview
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Brief Summary
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The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies

Detailed Description
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The main purpose of this Phase I study is to test RC88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

Official Title
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An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

Conditions
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Advanced Solid Tumours

Intervention / Treatment
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* Drug: RC88


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must be ≥ 18 years at the first screening examination / visit. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. Life expectancy of at least 12 weeks Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant,unable to receive, or nonexistent to standard care,Patients with partial,advanced or metastatic malignant solid tumors; Phase II-Advanced malignant solid tumor with MSLN expression Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory. Adequate organ function Voluntarily sign an informed consent form 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: Experimental: RC88<br>Subjects will receive intravenous infusion of RC88 once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs | Drug: RC88<br>* Every 2 weeks for a maximum of 2 years<br>* Other names: The injectable RC88;|

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 | 28 days after first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (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 | 
| Terminal Half Life (t1/2) 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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 24 months |