A Study of PHST001 in Advanced Solid Tumors
Summary
This is a multi-center, first-in-human (FIH), open-label, Phase 1a/1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.
Timeline
- Start
- 2025-03-31
- Primary completion
- 2029-04
- Completion
- 2031-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Irinotecan | Small molecule | — | — |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | PHST001 | Unknown | 0.1 mg/kg | Intravenous |
| Subject | PHST001 | Unknown | 0.3 mg/kg | Intravenous |
| Subject | PHST001 | Unknown | 1 mg/kg | Intravenous |
| Subject | PHST001 | Unknown | 2 mg/kg | Intravenous |
| Subject | PHST001 | Unknown | 4 mg/kg | Intravenous |
| Subject | PHST001 | Unknown | 6 mg/kg | Intravenous |
| Subject | PHST001 | Unknown | 9 mg/kg | Intravenous |
| Subject | PHST001 | Unknown | 18 mg/kg | Intravenous |
| Subject | PHST001 | Unknown | 36 mg/kg | Intravenous |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | Topotecan | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |