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NCT06265688PHASE1Recruiting

First In Human Study of CX-2051 in Advanced Solid Tumors

CytomX Therapeutics

Start Date

4/2/2024

Completion Date

3/31/2029

Summary

The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors.

Detailed Description

The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051 as monotherapy and as combination therapy (CX-2051 combined with bevacizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 as monotherapy and/or 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 * 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 * Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1 * Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload * Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1 * Elevated baseline laboratory values * Serious concurrent illness * Pregnant or breast feeding * Additional exclusion criteria may apply

Interventions

DRUG

CX-2051

DRUG

Bevacizumab

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Conditions

Solid Tumor, Adult

Locations

Sarah Cannon Research Institute at HealthONE

Denver, Colorado 80218

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Carolina BioOncology Institute, PLLC

Huntersville, North Carolina 28078

United States

Sarah Cannon Research Institute, LLC

Nashville, Tennessee 37203

United States

START - Dallas/Fort Worth

Fort Worth, Texas 76104

United States

START San Antonio LLC

San Antonio, Texas 78229

United States

NEXT Virginia

Fairfax, Virginia 22031

United States