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

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.

Conditions

Solid Tumor, Adult

Study Overview

Study Details

Study overview

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.

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

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco, San Francisco, California, United States, 94158

Pittsburgh

University of Pittsburgh Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15232

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 immunotherapy 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CytomX Therapeutics,

Monika Vainorius, MD, STUDY_DIRECTOR, CytomX Therapeutics

Study Record Dates

2029-06-30