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

Description

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.

Conditions

Solid Tumor, Adult

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Huntersville

Carolina BioOncology Institute, PLLC, Huntersville, North Carolina, United States, 28078

Nashville

Sarah Cannon Research Institute, LLC, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CytomX Therapeutics,

Monika Vainorius, MD, STUDY_DIRECTOR, CytomX Therapeutics

Study Record Dates

2029-03-31