Back to Trials
NCT06840886PHASE1Recruiting

A Study of PHST001 in Advanced Solid Tumors

Pheast Therapeutics

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

Key Inclusion Criteria: * Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies. * Adequate organ function per laboratory testing * Pregnancy prevention requirements * Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator/radiology * Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale Key Exclusion Criteria: * Diagnosis of immunodeficiency * History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded. * Active known CNS metastases and/or carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \[note that the repeat imaging should be performed during study screening\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment. * Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible. * Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant. * Received previous treatment with another agent targeting CD24.

Interventions

BIOLOGICAL

PHST001

DRUG

Chemotherapy per Standard of Care

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Advanced Solid TumorsOvarian CancerEndometrial CancerCholangiocarcinomaCNS Tumor

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