RECRUITING

A Study of PHST001 in Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-03-31

Study Completion:2031-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06840886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Raphaël Rousseau, Chief Medical Officer, PhD, MD

CONTACT

650-374-2223

PHST001_101@pheast.com

Study Locations (Sites)

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Pheast Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31

Study Completion Date2031-04

Study Record Updates

Study Start Date2025-03-31

Study Completion Date2031-04

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumors