Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06462794

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

Led by CytomX Therapeutics · Updated on 2026-03-24

121

Participants Needed

2

Research Sites

252 weeks

Total Duration

On this page

Sponsors

C

CytomX Therapeutics

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Recent history (within last 2 years) of localized cancers 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 stopped 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Pittsburgh Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

2

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

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Research Team

K

Karen Deane

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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