First In Human Study of CX-2051 in Advanced Solid Tumors

Last updated: January 17, 2025
Sponsor: CytomX Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

CX-2051

Clinical Study ID

NCT06265688
CTMX-2051-101
  • Ages > 18
  • All Genders

Study Summary

The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult participants with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Metastatic or locally advanced unresectable solid tumor that has progressed afterstandard 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

  • Additional inclusion criteria may apply

Exclusion

Exclusion Criteria:

  • Recent history (within last 2 years) of localized cancers that are not related tothe current cancer being treated

  • Known active central nervous system (CNS) involvement by malignancy

  • Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14days prior to C1D1

  • Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitorpayload

  • Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1

  • Elevated baseline laboratory values

  • Serious concurrent illness

  • Pregnant or breast feeding

  • Additional exclusion criteria may apply

Study Design

Total Participants: 124
Treatment Group(s): 1
Primary Treatment: CX-2051
Phase: 1
Study Start date:
April 02, 2024
Estimated Completion Date:
March 31, 2029

Study Description

The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051. Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 in indication-specific expansion cohorts.

Connect with a study center

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Carolina BioOncology Institute, PLLC

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute, LLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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