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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 malignancy
Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event
Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment
Investigational drug or device within 4 weeks prior to first dose of study treatment
Radiation within 2 weeks prior to first dose of study treatment
Serious concurrent illness
Pregnant or breast feeding
Clareo Health | First In Human Study of CX-801 in Advanced Solid Tumors
