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

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 dos

Trial Details

NCT ID
NCT06902350
Phase
PHASE1
Sponsor
Chipscreen Biosciences, Ltd.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • CS231295
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Changchun, Jilin, China|43.88,125.32278

Key Eligibility Criteria

  • Understand and sign the informed consent form voluntarily.
  • ≥18 years old when signing the informed consent, regardless of sex.
  • Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors (including but not limited to small cel…
  • Radiological or histopathological evidence indicating disease progression should be documented.

For full eligibility, visit ClinicalTrials.gov.

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