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
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.
Arms & interventions
- DrugFT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
- DrugPaclitaxel
IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
- DrugCetuximab
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
- DrugTrastuzumab
trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
Outcome measures
Primary
Number of participants with dose limiting toxicities (DLTs)
The number of participants experiencing ≥1 DLT will be reported.
Time frame: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
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).
Time frame: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
Secondary
Overall Response Rate (ORR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Progression-Free Survival (PFS)
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Eligibility criteria
Study locations (5)
University of Southern California
La Jolla, California, 90033
UC San Diego Moores Cancer Center
La Jolla, California, 92093
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
M. D. Anderson Cancer Center
Houston, Texas, 77030