RecruitingPhase 1NCT06462794

First In Human Study of CX-801 in Advanced Solid Tumors

An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors

Sponsor

CytomX Therapeutics

Enrollment

121 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

Solid Tumor, Adult

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria8

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