An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
CytomX Therapeutics
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Measurable disease per RECIST v1.1 * Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue * Adequate organ function * Additional inclusion criteria may apply Exclusion Criteria: * Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated * Known active central nervous system (CNS) involvement by…
Interventions
- DrugCX-801
Investigational drug
- Drugpembrolizumab
Standard of Care Therapy
Locations (2)
- University of Pittsburgh Hillman Cancer CenterPittsburgh, Pennsylvania
- SCRI Oncology PartnersNashville, Tennessee