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

Eligibility: Inclusion Criteria
  •   Key
  •   * 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.