A Study of PHST001 in Advanced Solid Tumors
Start Date
3/31/2025
Completion Date
4/1/2031
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PHST001
Chemotherapy per Standard of Care
Conditions
Locations
Precision NextGen Oncology & Research Center
Beverly Hills, California 90212
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Stanford University School of Medicine
Palo Alto, California 94304
United States
Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One
Denver, Colorado 80218
United States
Yale Cancer Center
New Haven, Connecticut 06520
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
START Center for Cancer Research - Midwest
Grand Rapids, Michigan 49546
United States
START Center for Cancer Research - Long Island New York
Lake Success, New York 11042
United States
Mount Sinai
New York, New York 10029
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee 37203
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37203
United States
START Center for Cancer Research - Texas
Fort Worth, Texas 76104
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology - Dallas
Irving, Texas 75039
United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas 78229
United States
University of Texas (UT) Health
San Antonio, Texas 78229
United States
NEXT Oncology - Virginia
Fairfax, Virginia 22031
United States