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A Study of PHST001 in Advanced Solid Tumors
Sponsor: Pheast Therapeutics
Summary
PHST001-101 is a multicenter, open-label, Phase 1 study of PHST001 in patients with advanced solid tumors. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced relapsed and/or refractory solid tumors. The study's primary object is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001.
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
155
Start Date
2025-03-31
Completion Date
2031-04
Last Updated
2025-09-04
Healthy Volunteers
No
Conditions
Interventions
PHST001
* PHST001 will be administered as IV infusions in a 3-week (Q3W) dosing interval. The dosing day will be on Day 1, 21 days cycle. * Other Names: * Dose Level 1 * Dose Level 2 * Dose Level 3 * Dose Level 4 * Dose Level 5 * Dose Level 6 * Dose Level 7 Drug: PHST001 * PHST001 will be administered as IV infusions in a 3-week (Q3W) dosing interval. The dosing day will be on Day 1, 21 days cycle. This study is an open label, Phase 1 dose escalation trial with three expansion cohorts. The study consists of two parts: * Part A: Dose escalation in patients with advanced solid tumors. Approximately 40-80 in total will be in enrolled in part A, covering 7 dose level. * Part B: Expansion cohorts will be added as an amendment as further preclinical data and clinical data from Part A become available.
Locations (10)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford University School of Medicine
Palo Alto, California, 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
Duke Cancer Institute
Durham, North Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States