Recruiting
Phase 1

FT825/ONO-8250 & Monoclonal Antibodies

Sponsor:

Fate Therapeutics

Code:

NCT06241456

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FT825

Fludarabine

Cyclophosphamide

Bendamustine

Docetaxel

Study Details

Brief summary:

This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.

Conditions

Advanced Solid Tumor

Study ID

NCT06241456

Start date

Jan 5, 2024

Status verified date

Dec, 2024

Completion date

May 1, 2044

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria
  • Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types
  • Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • 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
  • Anticipated life expectancy of at least 3 months

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Evidence of inadequate organ function
  • Clinically significant cardiovascular disease
  • Known active central nervous system (CNS) involvement by malignancy
  • Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment
  • Active bacterial, fungal, or viral infections
  • Prior receipt of chimeric antigen receptor (CAR) T-cell therapy, other cellular therapy, or a FATE investigational human induced pluripotent stem cell (iPSC) product
  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out based on imaging at screening
  • 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
  • Active or history of autoimmune disease or immune deficiency
  • Receipt of an allograft organ transplant

Study Design

Enrollment

351 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Regimen A: FT825

Participants with advanced HER2-expressing solid tumors receive FT825 following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment).

experimental: Regimen B: FT825 + Cetuximab

Participants with advanced epidermal growth factor receptor (EGFR)-expressing solid tumors receive FT825 in combination with cetuximab following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment).

Interventions

FT825

FT825 will be administered as an intravenous (IV) infusion at planned dose levels.

Fludarabine

Fludarabine will be administered as an IV infusion at planned dose levels.

Cyclophosphamide

Cyclophosphamide will be administered as an IV infusion at planned dose levels.

Bendamustine

Bendamustine will be administered as an IV infusion at planned dose levels.

Docetaxel

Docetaxel will be administered as an IV infusion at planned dose levels.

Cisplatin

Cisplatin will be administered as an IV infusion at planned dose levels.

Cetuximab

Cetuximab will be administered as an IV infusion at planned dose levels.

Primary outcome measure

  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to approximately 29 days ]
  • Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 2 years ]
  • Severity of AEs [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Fate Trial Disclosure

858-875-1800FateTrialDisclosure@fatetherapeutics.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

University of California San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

Yale New Haven Hospital - Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

University of Minnesota Medical School

Recruiting

Minneapolis, Minnesota, United States, 55455

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Oncology Hematology Care Clinial Trials

Recruiting

Cincinnati, Ohio, United States, 45242

Ohio State University - Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Thomas Jefferson University, Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Sarah Cannon Research Institute (SCRI) - Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Fate Therapeutics

Last update posted

Dec 9, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fate Therapeutics on 2025-12-09.