A Study of CS231295 in Patients With Advanced Solid Tumors
Summary
This is a Phase I, single-arm, open-label, dose-escalation, multicenter clinical study of CS231295 in patients with advanced solid malignant tumors. Eligible patients must be 18 years or older and have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors, who have failed or are intolerant to previous standard treatments and currently have no other standard treatment options available. Patients should have at least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1) and a Karnofsky Performance Status (KPS) score ≥ 60 (glioma) or an ECOG Performance Status score of 0 or 1 (other solid tumors). After screening, eligible patients will be enrolled sequentially in the dose-escalating cohorts.
Timeline
- Start
- 2026-06
- Primary completion
- 2027-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CS231295 | Small molecule | 20 mg | Oral |
| Subject | CS231295 | Small molecule | 30 mg | Oral |
| Subject | CS231295 | Small molecule | 40 mg | Oral |
| Subject | CS231295 | Small molecule | 50 mg | Oral |