OncoMatch/Clinical Trials/NCT06902350
Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors
Is NCT06902350 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06902350 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Aurora kinase inhibitor disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages