FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
Fate Therapeutics
Study ID
NCT07216105
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FT836 — DRUG
    FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
  • Cetuximab — DRUG
    Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
  • Trastuzumab — DRUG
    Trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.

Study Details

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

Key Dates

First listed
Oct 14, 2025
Start date
Nov 4, 2025
Status verified
Aug 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
119 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A
    CY/FLU followed by FT836
  • Experimental: Regimen B
    Standard-of-care (SOC) chemotherapy followed by FT836
  • Experimental: Regimen C
    FT836 combined with cetuximab
  • Experimental: Regimen D
    CY/FLU followed by FT836 combined with cetuximab
  • Experimental: Regimen D1
    SOC chemotherapy followed by FT836 combined with cetuximab
  • Experimental: Regimen E
    FT836 combined with trastuzumab
  • Experimental: Regimen F
    CY/FLU followed by FT836 combined with trastuzumab
  • Experimental: Regimen F1
    SOC chemotherapy followed by FT836 combined with trastuzumab

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) [ Time Frame: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of Southern CaliforniaLos AngelesCalifornia90033-
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455
Principle Investigator
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107
Principle Investigator
M. D. Anderson Cancer CenterHoustonTexas77030
Principle Investigator

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