Clinical Trial

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

Recruiting Phase 1
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-23.
Status change: Not Yet Recruiting → Recruiting 2025-05-22
Trial Details
NCT Number NCT06902350
Lead Sponsor Chipscreen Biosciences, Ltd.
Conditions Neoplasms, Glioblastoma, Adult, Small Cell Lung Carcinoma (SCLC)
Enrollment 102 participants
Start Date 2025-05-21
Primary Completion 2029-04 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2025-05-25