A Study of PHST001 in Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumors, Ovarian Cancer, Endometrial Cancer, Cholangiocarcinoma, CNS Tumor
In brief
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.
Key facts
- Study ID
- NCT06840886
- Run by
- Pheast Therapeutics
- People needed
- 272
- Starts
- 2025-03-31
- Expected to finish
- 2031-04-01
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Precision NextGen Oncology & Research Center — Beverly Hills, California, United States (enrolling)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Stanford University School of Medicine — Palo Alto, California, United States (enrolling)
- Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One — Denver, Colorado, United States (enrolling)
- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States (enrolling)
- START Center for Cancer Research - Midwest — Grand Rapids, Michigan, United States (enrolling)
- START Center for Cancer Research - Long Island New York — Lake Success, New York, United States (enrolling)
- Mount Sinai — New York, New York, United States (enrolling)
- Duke Cancer Institute — Durham, North Carolina, United States (enrolling)
- Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville, Tennessee, United States (enrolling)
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
- START Center for Cancer Research - Texas — Fort Worth, Texas, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- NEXT Oncology - Dallas — Irving, Texas, United States (enrolling)
- South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States (enrolling)
- University of Texas (UT) Health — San Antonio, Texas, United States (enrolling)
- NEXT Oncology - Virginia — Fairfax, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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