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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 anticancer therapies (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). Phase 1b will include the following cohorts 1) tumor-specific cohorts for participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma, 2) a randomized cohort for participants with ovarian cancer who will receive PHST001 in combination with mirvetuximab soravtansine, 3) a cohort for participants with advanced/metastatic breast cancer who will receive PHST001 in combination with trastuzumab deruxtecan and 4) a cohort of patients who consent to additional biomarker studies. The study's primary objectives are to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 as monotherapy and in combination with anticancer therapies, as well as to assess the anti-tumor activity of PHST001 in combination with anticancer therapies 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
426
Start Date
2025-03-31
Completion Date
2031-04
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
PHST001
PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.
Paclitaxel
Paclitaxel used as per standard of care.
Topotecan
Topotecan used as per standard of care.
Doxorubicin
Doxorubicin used as per standard of care.
FOLFIRI
FOLFIRI used as per standard of care.
FOLFOX
FOLFOX used as per standard of care.
Gemcitabine
Gemcitabine used as per standard of care.
Mirvetuximab Soravtansine
Mirvetuximab soravtansine used as per standard of care.
Trastuzumab Deruxtecan
Trastuzumab deruxtecan used as per 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
START Center for Cancer Research - San Antonio
San Antonio, Texas, United States
University of Texas (UT) Health
San Antonio, Texas, United States
NEXT Oncology - Virginia
Fairfax, Virginia, United States