A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
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.
• 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, ALP ≤5 × ULN
⁃ Oxygen saturation \>90% on room air
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention.
• Presence of baseline safely accessible lesions of adequate size for on-treatment biopsies (exceptions for lesion size may be granted with medical monitor approval) and participant willingness to undergo protocol prescribed on-treatment biopsies.