An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors

Study Identifier:
CTMX-2051-101
CT.gov Identifier:
NCT06265688
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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.

The Phase 1 dose escalation is designed to efficiently test the safety and preliminary anti-tumor activity of CX-2051, to provide initial clinical proof of concept to inform a potential decision to move into dose expansions

To study theCX-2051 in patients with EpCAM positive tumors including colorectal Cancer

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: CX-2051
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion 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
    • - Additional inclusion criteria may apply
    Exclusion criteria
    • - 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
    • - Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14
    • days prior to C1D1
    • - Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload
    • - 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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor