An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors
Summary
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.
Detailed description
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.
Arms & interventions
- DrugCX-2051
Investigational drug
- DrugBevacizumab
IV infusion
Outcome measures
Primary
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
Secondary
Objective response rate (ORR)
Time frame: 60 months
Duration of response (DOR)
Time frame: 60 months
Progression-free survival (PFS)
Time frame: 60 months
Time to Treatment Failure (TTF)
Time frame: 60 months
Disease control rate (DCR)
Time frame: 60 months
Duration of disease control (DODC)
Time frame: 60 months
Overall survival (OS)
Time frame: 60 months
Eligibility criteria
Study locations (7)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Montefiore Medical Center
The Bronx, New York, 10461
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, 28078
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, 37203
START San Antonio LLC
San Antonio, Texas, 78229
NEXT Virginia
Fairfax, Virginia, 22031