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RECRUITING
NCT06902350
PHASE1

Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors

Sponsor: Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

Summary

This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. The overall study consists of screening period, treatment period, and follow-up period. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients with advanced solid tumors, and to recommended Phase 2 dose(s) (RP2D) of CS231295 in appropriate tumor(s).

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CS231295 in Subjects With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2025-05-21

Completion Date

2029-04

Last Updated

2025-05-25

Healthy Volunteers

No

Interventions

DRUG

CS231295

oral tablet. Only one dose on C0D1 in single-dose period. Once daily from C1D1 until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or the end of the trial, whichever occurs first, in multiple-dose period in both escalation and cohort expansion phases.

Locations (2)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Jilin Cancer Hospital

Changchun, Jilin, China