Phase I
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 HIC#:2000039749
- Last Updated:07/16/2025
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.
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Key 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.