RecruitingPhase 1NCT06265688

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

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


Sponsor

CytomX Therapeutics

Enrollment

160 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria8

  • 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

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Interventions

DRUGCX-2051

Investigational drug

DRUGBevacizumab

IV infusion


Locations(5)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Carolina BioOncology Institute, PLLC

Huntersville, North Carolina, United States

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, United States

START San Antonio LLC

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06265688


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