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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
Trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
UC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
RECRUITINGUniversity of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
RECRUITINGThomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGM. D. Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNumber of participants with dose limiting toxicities (DLTs)
The number of participants experiencing ≥1 DLT will be reported.
Time frame: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
Severity of DLTs
The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).
Time frame: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
Overall Response Rate (ORR)
Participants will be classified into the following tumor response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) per RECIST v1.1. The best overall response (BOR) will be summarized for the efficacy evaluable population. ORR is defined as the percentage of participants who achieve a PR or better during the study prior to any subsequent off-protocol anti-cancer therapy.
Time frame: Up to approximately 24 months
Duration of Response (DOR)
The DOR is defined as the time from first objective response to disease progression or death from any cause.
Time frame: Up to approximately 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from first study intervention to progressive disease or death from any cause.
Time frame: Up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from first dose of study intervention to death from any cause.
Time frame: Up to approximately 24 months
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