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

Study Identifier:
PHST001-101
CT.gov Identifier:
NCT06840886
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

To evaluate PHST001 in combination with chemotherapy.

To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PHST001 in combination with established chemotherapy regimens using a suitable dose identified by the Phase 1a portion.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Dallas Fort Worth
    Fort Worth, TX, United States, 76104
    Investigator
    Henry Xiong
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor