Recruiting
Phase 1

CX-801

Sponsor:

CytomX Therapeutics

Code:

NCT06462794

Conditions

Solid Tumor, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CX-801

pembrolizumab

Study Details

Brief 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.

Conditions

Solid Tumor, Adult

Study ID

NCT06462794

Start date

Aug 28, 2024

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Feb 28, 2028

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
  • 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

Study Design

Enrollment

121 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CX-801

experimental: CX-801 + pembrolizumab

Interventions

CX-801

Investigational drug

pembrolizumab

Standard of Care Therapy

Primary outcome measure

  • Safety and tolerability of CX-801 as monotherapy and combination therapy [ Time Frame: 44 months ]
  • Determine the recommended Phase 2 dose (RP2D) [ Time Frame: 44 months ]

Central Contacts and Locations

Central contacts

Karen Deane

650-515-3185clinicaltrials@cytomx.com

Locations

The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate

Recruiting

Los Angeles, California, United States, 90025

The Melanoma and Skin Cancer Institute

Recruiting

Englewood, Colorado, United States, 80113

University of Pittsburgh Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

START Dallas Fort Worth, LLC

Recruiting

Fort Worth, Texas, United States, 76104

More Information

Sponsor

CytomX Therapeutics

Last update posted

Aug 28, 2026

Last verified

Aug, 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 2026-08-28.