A Study of CS1002 in Subjects With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.

Official Title
-----------------
A Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors

Conditions
-----------------
Solid Tumor, Adult

Intervention / Treatment
-----------------
* Drug: CS1002
* Drug: CS1003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable. ECOG performance status of 0 or 1. Life expectancy ≥12 weeks. Subjects must have adequate organ function Use of effective contraception 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. Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002. Has received prior therapy with an anti-CTLA-4 agent. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has not recovered from adverse events due to prior therapy. Receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of CS1002. Receipt of live vaccine within 28 days prior to the first dose of CS1002 Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies. Known history of HIV. Subjects with active Hepatitis B or C infection Subjects with active tuberculosis infection. Subjects with an active infection requiring systemic therapy. History of organ transplantation. History of alcoholism or drugs abuse. History of severe hypersensitivity reactions to other mAbs. Subjects with major cardiovascular diseases. For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS1002<br>Participants will receive CS1002 intravenously at specified dose on specified days. | Drug: CS1002<br>* Dose levels will be escalated following a modified 3+3 dose escalation scheme<br>* Other names: anti-CTLA 4;Drug: CS1003<br>* Fixed dose at 200mg in combination with CS1002 on a specified dose level<br>* Other names: anti-PD1;|
| Experimental: CS1003<br>Participants will receive CS1003 intravenously at fixed dose on specified days. | Drug: CS1002<br>* Dose levels will be escalated following a modified 3+3 dose escalation scheme<br>* Other names: anti-CTLA 4;Drug: CS1003<br>* Fixed dose at 200mg in combination with CS1002 on a specified dose level<br>* Other names: anti-PD1;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | From the day of first dose to 30 days after last dose of CS1002 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid Tumors