OncoMatch/Clinical Trials/NCT06902350
Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors
Is NCT06902350 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CS231295 for neoplasms.
Treatment: CS231295 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Small Cell Lung Cancer
Disease stage
Required: Stage IV
unresectable advanced, recurrent, or metastatic solid tumors
Prior therapy
Must have received: systemic chemotherapy (platinum-based regimen) — SCLC, at least two lines
Cohort 1: Histologically or cytologically confirmed small cell lung cancer (SCLC) that has progressed or recurred after at least two lines of systemic chemotherapy (including a platinum-based regimen)
Must have received: temozolomide (temozolomide) — glioblastoma, at least one prior treatment
Cohort 2: Recurrent or progressive glioblastoma confirmed by histopathology or imaging, which has progressed or recurred after at least one prior treatment with temozolomide
Cannot have received: Aurora kinase inhibitor
Previously received Aurora kinase inhibitors
Lab requirements
Blood counts
Hemoglobin ≥100 g/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L.
Kidney function
Dose escalation: Cr ≤ULN. Cohort expansion: Cr ≤1.5×ULN.
Liver function
Dose escalation: TBIL ≤1.25×ULN; ALT, AST ≤1.5×ULN (≤3×ULN with liver mets/HCC). Cohort expansion: TBIL ≤1.5×ULN; ALT, AST ≤2.5×ULN (≤5×ULN with liver mets/HCC).
Cardiac function
LVEF <50% at screening excluded; NYHA Class II or higher CHF, unstable angina, MI within 6 months, arrhythmias requiring treatment, symptomatic CAD, significant QTcF prolongation, significant cerebrovascular accident within 6 months, use of ≥3 antihypertensive drugs or uncontrolled BP (SBP ≥140 mmHg or DBP ≥90 mmHg) at screening.
Meet the following laboratory criteria... (see full criteria for details).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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