First In Human Study of CX-801 in Advanced Solid Tumors
ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCytomX Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CX-801
- pembrolizumab
Treatment groups
121 Participants
are divided into 2 treatment groupsSponsors and collaborators
CytomX Therapeutics
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov