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
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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.
  • Paclitaxel — DRUG
    IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
  • 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 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.

Key Dates

Start date
Nov 4, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

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

Arms

  • Experimental: Regimen A ( FT836)
    Participants receive FT836 monotherapy
  • Experimental: Regimen B ( Paclitaxel + FT836)
    Participants receive Paclitaxel chemotherapy followed by FT836
  • Experimental: Regimen C ( Cetuximab + FT836)
    Participants receive FT836 combined with cetuximab
  • Experimental: Regimen D ( Paclitaxel + Cetuximab + FT836)
    Participants receive Paclitaxel chemotherapy followed by FT836 combined with cetuximab
  • Experimental: Regimen E ( Trastuzumab + FT836))
    Participants receive FT836 combined with trastuzumab
  • Experimental: Regimen F ( Paclitaxel + Trastuzumab + FT836)
    Participants receive Paclitaxel 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 CaliforniaLa JollaCalifornia90033-
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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By research site
UC San Diego Moores Cancer Center· La Jolla, CAUniversity of Southern California· La Jolla, CAUniversity of Minnesota Masonic Cancer Center· Minneapolis, MNThomas Jefferson University, Sidney Kimmel Cancer Center· Philadelphia, PAM. D. Anderson Cancer Center· Houston, TX

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