NCT06902350

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Neoplasms
• Glioblastoma, Adult
• Small Cell Lung Carcinoma (SCLC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-21
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2025-03-30
• Last updated: 2025-05-25

Locations

2 sites across 1 country: China