Recruiting
Phase 1

FT836 with Paclitaxel, Trastuzumab, Cetuximab

Sponsor:

Fate Therapeutics

Code:

NCT07216105

Conditions

Non-Small Cell Lung Cancer

Colorectal Cancer

Breast Cancer

Ovarian Cancer

Endometrial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FT836

Cetuximab

Trastuzumab

Study Details

Brief 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 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

Conditions

Non-Small Cell Lung Cancer

Colorectal Cancer

Breast Cancer

Ovarian Cancer

Endometrial Carcinoma

Study ID

NCT07216105

Start date

Nov 4, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • For all regimens, disease that is not amenable to curative therapy and that has relapsed or progressed following at least one line of prior systemic therapy.
  • Evidence of adequate organ function as determined by all of the following:

  • Absolute neutrophil count (ANC) >1000/µL without growth factor support within 7 days prior to start of first study intervention
  • Platelet count ≥75,000/µL without transfusion support within 14 days prior to start of first study intervention
  • Estimated creatinine clearance ≥50 mL/minute by Cockcroft-Gault method or other standard institutional method
  • Total bilirubin ≤1.5 × upper limit of normal (ULN); for participants with documented Gilbert syndrome, total bilirubin must be ≤3 ×ULN
  • Aspartate transaminase (AST) ≤3 × ULN or alanine transaminase (ALT) ≤3 × ULN; in participants with documented liver metastases, AST or ALT ≤5 × ULN
  • Alkaline phosphatase (ALP) ≤2.5 × ULN; in participants with documented liver or bone metastases, ALP ≤5 × ULN
  • Oxygen saturation >90% on room air
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention.
  • Presence of baseline safely accessible lesions of adequate size for on-treatment biopsies (exceptions for lesion size may be granted with medical monitor approval) and participant willingness to undergo protocol prescribed on-treatment biopsies.

Exclusion Criteria:

  • Clinically significant cardiovascular disease including any of the following: uncontrolled/ unstable cardiac arrhythmias, myocardial infarction within 6 months prior to start of first study intervention, unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher, or cardiac ejection fraction <50%.
  • Receipt of any biological therapy, chemotherapy, investigational therapy, or radiation therapy within 2 weeks or five half-lives prior to start of first study intervention, whichever is shorter.
  • Known active central nervous system (CNS) involvement by malignancy. Participants with prior CNS involvement from their malignancy must have completed effective treatment of their CNS disease with no symptoms of disease in the absence of steroid treatment and at least stable findings on relevant CNS imaging and no evidence of leptomeningeal disease for at least 4 weeks prior to study enrollment.
  • Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 6 months prior to study enrollment.
  • Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone ≥5 mg daily) for any reason from start of first study intervention to Day 29 with the exception of corticosteroids as a premedication for chemotherapy side effects per institutional standard of care or as mandated by the protocol.
  • Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase.
  • Grade ≥2 peripheral neuropathy limiting instrumental activities of daily living.

Study Design

Enrollment

119 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

FT836

FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.

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.

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) ]
  • Severity of DLTs [ Time Frame: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days) ]

Central Contacts and Locations

Central contacts

Fate Trial Disclosure

858-875-1800FateTrialDisclosure@fatetherapeutics.com

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

University of Minnesota Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Thomas Jefferson University, Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Fate Therapeutics

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • HNSCC, NSCLC, CRC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Fate Therapeutics on 2026-09-02.