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FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Sponsor: Fate Therapeutics
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
113
Start Date
2025-11-04
Completion Date
2030-01
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Paclitaxel
IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
Cetuximab
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
Trastuzumab
trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
Locations (5)
University of Southern California
La Jolla, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
M. D. Anderson Cancer Center
Houston, Texas, United States