The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.
The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Investigational drug
Standard of Care Therapy
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States
RECRUITINGThe Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
RECRUITINGUniversity of Pittsburgh Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Safety and tolerability of CX-801 as monotherapy and combination therapy
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
Disease 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
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SCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGSTART Dallas Fort Worth, LLC
Fort Worth, Texas, United States
RECRUITINGDuration 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