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A Study of PHST001 in Advanced Solid Tumors
Sponsor: Pheast Therapeutics
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.
Official title: An Open-label, Phase 1a/1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and/or Refractory Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
272
Start Date
2025-03-31
Completion Date
2031-04
Last Updated
2026-05-14
Healthy Volunteers
No
Interventions
PHST001
PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.
Chemotherapy per Standard of Care
Participants will receive PHST001 at a dose level and schedule based on monotherapy data in Phase 1a. PHST001 will be combined with chemotherapeutic agents used as standard of care.
Locations (20)
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
START Center for Cancer Research - Midwest
Grand Rapids, Michigan, United States
START Center for Cancer Research - Long Island New York
Lake Success, New York, United States
Mount Sinai
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
START Center for Cancer Research - Texas
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology - Dallas
Irving, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
University of Texas (UT) Health
San Antonio, Texas, United States
NEXT Oncology - Virginia
Fairfax, Virginia, United States