A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors

Last updated: April 28, 2025
Sponsor: CytomX Therapeutics
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Solid Tumors

Treatment

CX-904

Clinical Study ID

NCT05387265
CTMX-904-101
  • Ages > 18
  • All Genders

Study Summary

The purpose of this first-in-human study, CTMX-904-101, is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-904 in adult subjects with metastatic or locally advanced unresectable solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed metastatic or locally advanced unresectable solid tumor.Must have received prior standard therapy.

  • Measurable disease per RECIST 1.1

  • Eastern Cooperative Oncology Group performance status of 0 or 1

  • Adequate baseline laboratory values

  • Patients of childbearing potential or those with partners of childbearing potentialmust agree to use a highly effective method of birth control from signing the ICF,and for a period of 30 days after the last dose of CX-904.

  • Additional inclusion criteria may apply

Exclusion

Exclusion Criteria:

  • History of malignancy that was active within the previous 2 years. Exceptionsinclude localized cancers that are not related to the current cancer being treated,that are considered to have been cured, and in the opinion of the Investigator,present a low risk of recurrence

  • Screening electrocardiogram demonstrating a mean QTcF value > 480 msec; a screeningechocardiogram with left ventricular ejection fraction (LVEF) < 50%

  • Serious concurrent illness

  • History of or current active autoimmune diseases

  • History of myocarditis regardless of the cause

  • Pregnant or breast feeding

  • Additional exclusion criteria may apply

Study Design

Total Participants: 83
Treatment Group(s): 1
Primary Treatment: CX-904
Phase: 1
Study Start date:
May 16, 2022
Estimated Completion Date:
August 31, 2025

Study Description

This is a first-in-human study evaluating the safety, tolerability, and activity of CX-904, a conditionally activated T-cell bispecific to EGFR and CD3. The design includes single patient cohorts and a 3+3 design. Escalating dose increments will be determined in discussion with a Safety Review Committee.

Connect with a study center

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Site Not Available

  • Sarah Cannon Research Institute, LLC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Virginia Cancer Specialist

    Fairfax, Virginia 22031
    United States

    Site Not Available

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