Recruiting
Phase 1

CX-2051

Sponsor:

CytomX Therapeutics

Code:

NCT06265688

Conditions

Solid Tumor, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CX-2051

Bevacizumab

Study Details

Brief 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.

Conditions

Solid Tumor, Adult

Study ID

NCT06265688

Start date

Apr 2, 2024

Status verified date

Jul, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CX-2051

experimental: CX-2051 + bevacizumab

Interventions

CX-2051

Investigational drug

Bevacizumab

IV infusion

Primary outcome measure

  • Safety and tolerability of CX-2051 [ Time Frame: 44 months ]
  • Determine the recommended Phase 2 dose (RP2D) [ Time Frame: 44 months ]

Central Contacts and Locations

Central contacts

Locations

Sarah Cannon Research Institute at HealthONE

Recruiting

Denver, Colorado, United States, 80218

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Carolina BioOncology Institute, PLLC

Recruiting

Huntersville, North Carolina, United States, 28078

Sarah Cannon Research Institute, LLC

Recruiting

Nashville, Tennessee, United States, 37203

START - Dallas/Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

START San Antonio LLC

Recruiting

San Antonio, Texas, United States, 78229

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

CytomX Therapeutics

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CytomX Therapeutics on 2026-07-15.