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RECRUITING
NCT06840886
PHASE1

A Study of PHST001 in Advanced Solid Tumors

Sponsor: Pheast Therapeutics

View on ClinicalTrials.gov

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

Interventions

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. * 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