Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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

Details

The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.

Keywords

Solid Tumor, Adult, Neoplasms, Pembrolizumab, CX-801 + pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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 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

Locations

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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
CytomX Therapeutics
ID
NCT06462794
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 121 study participants
Last Updated