drugset / Trial / NCT03592264
A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of OBI-3424 administered as a single agent.
Timeline
- Start
- 2018-07-02
- Primary completion
- 2024-02-13
- Completion
- 2024-03-21
Publications
- Tsimberidou AM, Verschraegen C, Sigal D, Lenz HJ, Hochster H, Baysal MA, Chakraborty A, Lee I, Ristoski K, Xu D. Phase 2 Dose Expansion Trial of OBI-3424, a DNA-Alkylating Prodrug, in Patients with Advanced Solid Tumors Expressing AKR1C3. Oncologist. 2026 Jul 2:oyag254. doi: 10.1093/oncolo/oyag254. Online ahead of print.
- Tsimberidou AM, Verschraegen CF, Wesolowski R, Shia CS, Hsu P, Pearce TE. Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, and clinical activity of OBI-3424 in patients with advanced or metastatic solid tumors. Br J Cancer. 2023 Aug;129(2):266-274. doi: 10.1038/s41416-023-02280-4. Epub 2023 May 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OBI-3424 | Small molecule | 1 mg/m2 | Intravenous |
| Subject | OBI-3424 | Small molecule | 2 mg/m2 | Intravenous |
| Subject | OBI-3424 | Small molecule | 4 mg/m2 | Intravenous |
| Subject | OBI-3424 | Small molecule | 6 mg/m2 | Intravenous |
| Subject | OBI-3424 | Small molecule | 8 mg/m2 | Intravenous |
| Subject | OBI-3424 | Small molecule | 10 mg/m2 | Intravenous |
| Subject | OBI-3424 | Small molecule | 12 mg/m2 | Intravenous |
| Subject | OBI-3424 | Small molecule | 14 mg/m2 | Intravenous |