A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.

Official Title
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A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: CS1001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected. ECOG performance status of 0 or 1. Subjects must have at least one measurable lesion. Patients with life expectancy ≥ 3 months. Subject must have adequate organ function. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for six months after last study drug administration. Exclusion Criteria: Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment. Known history of HIV infection. Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma. Known history of alcoholism or drugs abuse. For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS1001<br> | Drug: CS1001<br>* In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of CS1001 |  | From first dose to 30 days after last dose of CS1001, up to 2 years | 
| To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001 |  | From first dose to 30 days after last dose of CS1001, up to 2 years |