drugset / Trial / NCT05571969
Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase Ib, two-part, multi-center study. In Part 1, the study will evaluate the safety and tolerability, antitumor activity, pharmacokinetics, and determine the maximum tolerated dose (MTD) of 2X-121 monotherapy (at BID regimen) in patients with advanced solid tumors. In Part 2, the study will evaluate safety and tolerability, antitumor activity, pharmacokinetics and determine the MTD of dovitinib when given in combination with the MTD of 2X-121 determined in Part 1.
Timeline
- Start
- 2023-03-08
- Primary completion
- 2024-02-19
- Completion
- 2024-10-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 2X-121 | Small molecule | 600 mg | Oral |
| Subject | 2X-121 | Small molecule | 800 mg | Oral |
| Subject | 2X-121 | Small molecule | 1000 mg | Oral |
| Subject | Dovitinib | Small molecule | 300 mg | — |
| Subject | Dovitinib | Small molecule | 400 mg | — |
| Subject | Dovitinib | Small molecule | 500 mg | — |