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RECRUITING
NCT06840886
PHASE1

A Study of PHST001 in Advanced Solid Tumors

Sponsor: Pheast Therapeutics

View on ClinicalTrials.gov

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

BIOLOGICAL

PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

DRUG

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