RECRUITING

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

Talk to us

Conditions

Solid Tumor, Adult

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-28
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06462794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  3. * Measurable disease per RECIST v1.1
  4. * Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
  5. * Adequate organ function
  6. * Additional inclusion criteria may apply
  1. * Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
  2. * Known active central nervous system (CNS) involvement by malignancy
  3. * Prior immunotherapy discontinued due to grade 3 or higher immune related adverse event
  4. * Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment
  5. * Investigational drug or device within 4 weeks prior to first dose of study treatment
  6. * Radiation within 2 weeks prior to first dose of study treatment
  7. * Serious concurrent illness
  8. * Pregnant or breast feeding
  9. * Additional exclusion criteria may apply

Contacts and Locations

Study Contact

Karen Deane
CONTACT
650-515-3185
clinicaltrials@cytomx.com

Principal Investigator

Monika Vainorius, MD
STUDY_DIRECTOR
CytomX Therapeutics

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94158
United States
University of Pittsburgh Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: CytomX Therapeutics

  • Monika Vainorius, MD, STUDY_DIRECTOR, CytomX Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2024-08-28
Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor, Adult