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 chemotherapy and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 with or without chemotherapy and/or trastuzumab or cetuximab
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.
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
Clinically significant cardiovascular disease including any of the following: uncontrolled/ unstable cardiac arrhythmias, myocardial infarction within 6 months prior to start of first study intervention, unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher, or cardiac ejection fraction <50%.
Receipt of any biological therapy, chemotherapy, investigational therapy, or radiation therapy within 2 weeks or five half-lives prior to start of first study intervention, whichever is shorter.
Known active central nervous system (CNS) involvement by malignancy. Participants with prior CNS involvement from their malignancy must have completed effective treatment of their CNS disease with no symptoms of disease in the absence of steroid treatment and at least stable findings on relevant CNS imaging and no evidence of leptomeningeal disease for at least 4 weeks prior to study enrollment.
Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 6 months prior to study enrollment.
Sequential
FT836
DrugFT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Cetuximab
DrugCetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
Trastuzumab
DrugTrastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
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Treatment groupsSee each treatment group below.
Number of participants with dose limiting toxicities (DLTs)
The number of participants experiencing ≥1 DLT will be reported.
Severity of DLTs
The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).
Overall Response Rate (ORR)
Participants will be classified into the following tumor response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) per RECIST v1.1. The best overall response (BOR) will be summarized for the efficacy evaluable population. ORR is defined as the percentage of participants who achieve a PR or better during the study prior to any subsequent off-protocol anti-cancer therapy.
Duration of Response (DOR)
The DOR is defined as the time from first objective response to disease progression or death from any cause.
Progression-Free Survival (PFS)
PFS is defined as the time from first study intervention to progressive disease or death from any cause.
Overall Survival (OS)
OS is defined as the time from first dose of study intervention to death from any cause.
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