The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors.
The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051 as monotherapy and as combination therapy (CX-2051 combined with bevacizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 as monotherapy and/or combination therapy in indication-specific expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Investigational drug
IV infusion
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
Safety and tolerability of CX-2051
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Time frame: 44 months
Determine the recommended Phase 2 dose (RP2D)
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Time frame: 44 months
Objective response rate (ORR)
ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment
Time frame: 60 months
Duration of response (DOR)
DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Time frame: 60 months
Progression-free survival (PFS)
PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: 60 months
Time to Treatment Failure (TTF)
TTF defined as the time from first dose of study intervention to the date of premature discontinuation for any reason, including tumor progression, severe toxicity, participant withdrawal, or death.
Time frame: 60 months
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Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, United States
RECRUITINGSarah Cannon Research Institute, LLC
Nashville, Tennessee, United States
RECRUITINGSTART San Antonio LLC
San Antonio, Texas, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGDisease control rate (DCR)
DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.
Time frame: 60 months
Duration of disease control (DODC)
DODC defined as the time from the first documentation of confirmed CR, PR, or SD (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Time frame: 60 months
Overall survival (OS)
OS defined as the time from the first dose of study intervention to death due to any cause
Time frame: 60 months