Testing CX-801 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study evaluates the safety, tolerability, and antitumor activity of CX-801, both alone and in combination with pembrolizumab, in adults with advanced solid tumors. The study consists of two parts: the first part focuses on dose escalation to determine the maximum tolerated dose of CX-801, while the second part involves dose expansion to further assess safety and preliminary antitumor activity in specific cohorts. Participants will undergo fresh biopsies or provide archival tumor tissue for analysis.

Why it matters

Who can join: the full rules

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

Where it's running

• The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
  Los Angeles, California, United States Recruiting
• The Melanoma and Skin Cancer Institute
  Englewood, Colorado, United States Recruiting
• University of Pittsburgh Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• START Dallas Fort Worth, LLC
  Fort Worth, Texas, United States Recruiting

Study contacts

• Study coordinator: Karen Deane
• Email: clinicaltrials@cytomx.com
• Phone: 650-515-3185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.