A Study of PHST001 in Advanced Solid Tumors

Eligibility 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.