Advanced Solid Tumor
Conditions
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.
Interventions
DRUGFT825
FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
DRUGFludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
DRUGCyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
DRUGBendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
DRUGDocetaxel
Docetaxel will be administered as an IV infusion at planned dose levels.
DRUGCisplatin
Cisplatin will be administered as an IV infusion at planned dose levels.
DRUGCetuximab
Cetuximab will be administered as an IV infusion at planned dose levels.
Sponsors
Fate Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 2 years | OS defined as the time from first dose of study intervention to death from any cause. |
| Investigator-Assessed Overall Response Rate (ORR) | Up to approximately 2 years | ORR is the proportion of participants who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v.1.1). |
| Plasma Concentration of FT825 | At designated time points up to approximately 56 days | The plasma concentration of FT825 will be determined. |
| Investigator-Assessed Duration of Response (DOR) | Up to approximately 2 years | DOR is the duration from the first occurrence of a documented objective response of either PR or CR until the time of disease progression, or death from any cause, whichever occurs first, per RECIST, v.1.1. |
| Progression-Free Survival (PFS) | Up to approximately 2 years | PFS is the time from first dose of study intervention to disease progression, or to the day of death for any reason, whichever occurs first, per RECIST, v.1.1. |
Countries
United States
Contacts
Primary ContactFate Trial Disclosure
Outcome results
None listed