An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors

Study Identifier:
CTMX-801-101
CT.gov Identifier:
NCT06462794
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

To evaluate CX-801 as monotherapy and in combination with Keytruda in patients with advanced metastatic solid tumors including melanoma, renal cell carcinoma and head and neck squamous cell carcinomac

To evaluate safety and signs of clinical activity for CX-801 as monotherapy and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab).

To inform a potential decision to move into Phase 1b indication-specific dose expansion cohorts.

To evaluate CX-801 in combination with KEYTRUDA® has been initiated following successful the clearance of the first three CX-801 monotherapy dose escalation cohorts.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: CX-801
Read More
Drug: Drug: CX-801
Drug: Experimental: CX-801 + pembrolizumabDrug: CX-801
Drug: Drug: pembrolizumab
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

View Study Information

Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Henry Xiong
Status
Will Be Recruiting
Condition(s) Treated at Site
Solid Tumor