A Study of PHST001 in Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: PHST001

• Registration Number: NCT06840886
• Lead Sponsor: Pheast Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-21
• Study Start: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Primary Completion: 2029-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 155

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

Key

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	PHST001	Seven dose levels will be tested in dose escalation.

Primary Outcome Measures

Name	Time	Method
AE	90 days after the last dose of PHST001	Evaluate the safety and tolerability of PHST001
DLT	21 days after the first dose of PHST001	Evaluate the safety and tolerability of PHST001

Secondary Outcome Measures

Name	Time	Method
RECIST v1.1	From screening and during treatment up to 2 years	Assessment of preliminary antitumor activity of PHST001
PK	From treatment until 90 days after last dose of PHST001	Cmax of PHST001
PD	From treatment until end of treatment of up to 2 years of PHST001	RO (receptor occupancy) on peripheral neutrophils

Trial Locations

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