FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
NCT07216105 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2026-04-07
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.
Conditions
Interventions
- DRUG
-
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
- DRUG
-
IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
- DRUG
-
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
- DRUG
-
trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Brian Dempster · Fate Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-04
- Primary Completion
- 2028-01-31
- Completion
- 2030-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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