RecruitingPhase 1NCT06902350

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

Sponsor

Chipscreen Biosciences, Ltd.

Enrollment

102 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

Neoplasms Small Cell Lung Carcinoma (SCLC)Glioblastoma, Adult

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing the safety, drug behavior in the body (pharmacokinetics), and early effectiveness of CS231295 — a new investigational drug — in patients with advanced solid tumors that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older with confirmed advanced, recurrent, or metastatic solid tumors (such as lung, liver, bladder, endometrial, cervical, ovarian, or breast cancer) - Standard therapies have failed or were not tolerable - Your cancer has measurable evidence of progression - Your overall health and organ function meet the required levels **You may NOT be eligible if...** - You have active brain metastases that are unstable - You have severe autoimmune disease - You are pregnant or breastfeeding - You have serious uncontrolled infections or significant heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCS231295

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.