Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
UCLA Hematology/Oncology
Los Angeles, California, United States
RECRUITINGSarah Cannon Research Institute (SCRI)
Denver, Colorado, United States
Number of participants with Dose Limiting Toxicities (DLTs)
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol
Time frame: up to 21 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab
Time frame: up to 2 years
QTX3034 pharmacokinetic parameters in plasma
Plasma concentration data for QTX3034 will be used to evaluate PK parameters such as maximum concentration (Cmax), minimum concentration (Cmin), time to attain Cmax (Tmax), area under the concentration-time curve (AUC), elimination half-life (t1⁄2).
Time frame: up to 2 years
Objective response rate (ORR)
The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.
Time frame: up to 2 years
Duration of response (DOR)
Duration of response (DoR) is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR.
Time frame: up to 2 years
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Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGStephenson Cancer Center
Oklahoma City, Oklahoma, United States
RECRUITINGSCRI- Nashville
Nashville, Tennessee, United States
RECRUITING...and 4 more locations