drugset / Trial / NCT06598007
A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an FIH, multicenter, open-label, dose escalation and dose expansion/dose optimization study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2b. Phase 1 will be a standard 3+3 dose escalation and dose finding study in patients with advanced solid tumors for whom there is no available therapy (or patients are not candidates for such therapy) for the assessment of DLTs at up to 7 dose levels of CT3001. Phase 2b is a dose finding/dose optimization study of CT3001 in combination with SOC chemotherapy (FOLFOX) to evaluate the safety and preliminary efficacy of CT3001 in patients with advanced CRC who are eligible for re-engaging FOLFOX-based chemotherapy.
Timeline
- Start
- 2024-09-20
- Primary completion
- 2027-06-20
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CT3001 | Small molecule | 50 mg | Oral |
| Subject | CT3001 | Small molecule | 100 mg | Oral |
| Subject | CT3001 | Small molecule | 200 mg | Oral |
| Subject | CT3001 | Small molecule | 300 mg | Oral |
| Subject | CT3001 | Small molecule | 400 mg | Oral |
| Subject | CT3001 | Small molecule | 500 mg | Oral |
| Subject | CT3001 | Small molecule | 600 mg | Oral |
| Subject | CT3001 | Small molecule | 700 mg | Oral |
| Subject | CT3001 | Small molecule | 800 mg | Oral |
| Subject | CT3001 | Small molecule | 1000 mg | Oral |
| Background | Leucovorin | Small molecule | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |