A Study of PHST001 in Advanced Solid Tumors

NCT ID: NCT06840886

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2031-04-30

Brief 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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

Seven dose levels will be tested in dose escalation.

Group Type: EXPERIMENTAL

PHST001

Intervention Type: DRUG

• 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.

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.
• Adequate hepatic function:
• AST and ALT ≤ 2.5 × times ULN (≤ 5 × ULN if liver metastases)
• Total bilirubin ≤ 1.5 × ULN (<3 ×ULN for patients with elevations due to Gilbert syndrome)
• Lipase and amylase ≤ 2×ULN
• Adequate renal function: calculated creatinine clearance of ≥ 30 mL/min calculated per institutional standard
• Adequate bone marrow function without packed RBC transfusion within the prior 2 weeks. Patients can be on a stable dose of erythropoietin (approximately ≥ 3 months). Criteria must be met without platelet transfusion within 7 days of screening blood draw:
• Absolute neutrophil count (ANC) ≥1,500/µL
• Platelet count ≥100,000/µL
• Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La

Exclusion Criteria

• History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Patients 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. Patients 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. Patients with previously treated CNS metastases may participate provided they are radiologically stable (ie, 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. Patients must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Patients with Grade ≤2 neuropathy may be eligible. Patients 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pheast Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status: RECRUITING

Stanford University School of Medicine

Palo Alto, California, United States

Site Status: RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Site Status: RECRUITING

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Duke Cancer Institute

Durham, North Carolina, United States

Site Status: RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status: NOT_YET_RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Raphaël Rousseau, Chief Medical Officer, PhD, MD

Role: CONTACT

medical@pheast.com

650-260-8443

Other Identifiers

PHST001-101

Identifier Type: -

Identifier Source: org_study_id