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NCT06462794PHASE1Recruiting

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

CytomX Therapeutics

Start Date

8/28/2024

Completion Date

6/30/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 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 * Additional exclusion criteria may apply

Interventions

DRUG

CX-801

DRUG

pembrolizumab

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Conditions

Solid Tumor, Adult

Locations

The Melanoma and Skin Cancer Institute

Englewood, Colorado 80113

United States

University of Pittsburgh Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

START Dallas Fort Worth, LLC

Fort Worth, Texas 76104

United States