FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Trial Parameters
Brief Summary
This is a phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without paclitaxel and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 in combination with trastuzumab or cetuximab; each objective will be assessed with or without paclitaxel chemotherapy.
Eligibility Criteria
Inclusion Criteria: * For all regimens, disease that is not amenable to curative therapy and that has relapsed or progressed following at least one line of prior systemic therapy. * Evidence of adequate organ function as determined by all of the following: * Absolute neutrophil count (ANC) \>1000/µL without growth factor support within 7 days prior to start of first study intervention * Platelet count ≥75,000/µL without transfusion support within 14 days prior to start of first study intervention * Estimated creatinine clearance ≥50 mL/minute by Cockcroft-Gault method or other standard institutional method * Total bilirubin ≤1.5 × upper limit of normal (ULN); for participants with documented Gilbert syndrome, total bilirubin must be ≤3 ×ULN * Aspartate transaminase (AST) ≤3 × ULN or alanine transaminase (ALT) ≤3 × ULN; in participants with documented liver metastases, AST or ALT ≤5 × ULN * Alkaline phosphatase (ALP) ≤2.5 × ULN; in participants with documented liver or bone metastases,