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FT825

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Fate Therapeutics, Inc.|Last Updated: Dec 9, 2025

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment351
FDA Designations
No designations recorded
Clinical trial landscape

FT825 · 1 trial · 1 indication

Phase 1 1
NCT06241456FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid TumorsAdvanced Solid Tumor
RECRUITING351 Analytics
PHASE1RECRUITING
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of participants with dose limiting toxicities (DLTs)
Up to approximately 29 days

The number of participants with DLTs will be reported.

Number of participants with treatment-emergent adverse events (TEAEs)
Up to approximately 2 years

The number of participants with TEAEs will be reported.

Severity of AEs
Up to approximately 2 years

Severity of AEs will be determined according to appropriate rating scales for the type of event reported.

Secondary Endpoints
Investigator-Assessed Overall Response Rate (ORR)
Up to approximately 2 years
Investigator-Assessed Duration of Response (DOR)
Up to approximately 2 years
Progression-Free Survival (PFS)
Up to approximately 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Regimen A: FT825EXPERIMENTALParticipants 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).
Regimen B: FT825 + CetuximabEXPERIMENTALParticipants 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
NameTypeDescription
FT825DRUGFT825 will be administered as an intravenous (IV) infusion at planned dose levels.
FludarabineDRUGFludarabine will be administered as an IV infusion at planned dose levels.
CyclophosphamideDRUGCyclophosphamide will be administered as an IV infusion at planned dose levels.
BendamustineDRUGBendamustine will be administered as an IV infusion at planned dose levels.
DocetaxelDRUGDocetaxel will be administered as an IV infusion at planned dose levels.
CisplatinDRUGCisplatin will be administered as an IV infusion at planned dose levels.
CetuximabDRUGCetuximab will be administered as an IV infusion at planned dose levels.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

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 consi...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06241456primaryCompletionDate: changed
LOWMay 24, 2026NCT06241456studyFirstPostDate: changed