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

CStone Pharmaceuticals10 sites in 2 countries91 target enrollmentApril 26, 2018

ConditionsSolid Tumor, Adult

InterventionsCS1002 CS1003

DrugsCS1002 CS1003

Overview

Phase: Phase 1
Intervention: CS1002
Conditions: Solid Tumor, Adult
Sponsor: CStone Pharmaceuticals
Enrollment: 91
Locations: 10
Primary Endpoint: Number of participants with adverse events
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 26, 2018

End Date

January 18, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

CStone Pharmaceuticals

Responsible Party

Sponsor

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
•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 CS
•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 CS
•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 CS
•History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
•Known history of HIV.