An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
Summary
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.
Detailed description
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.
Arms & interventions
- DrugCX-801
Investigational drug
- Drugpembrolizumab
Standard of Care Therapy
Outcome measures
Primary
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
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
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 (3)
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
University of Pittsburgh Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
SCRI Oncology Partners
Nashville, Tennessee, 37203