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

Recruiting now · Phase 1

Conditions studied: Solid Tumor, Adult

In brief

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.

Key facts

Study ID

NCT06462794

Run by

CytomX Therapeutics

People needed

121

Starts

2024-08-28

Expected to finish

2029-06-30

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Melanoma and Skin Cancer Institute — Englewood, Colorado, United States (enrolling)
• University of Pittsburgh Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• START Dallas Fort Worth, LLC — Fort Worth, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.