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

May 15, 2026 updated by: CytomX Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 as monotherapy and as combination therapy (CX-2051 combined with bevacizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 as monotherapy and/or combination therapy in indication-specific expansion cohorts.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Carolina BioOncology Institute, PLLC
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute, LLC
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START San Antonio LLC
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CX-2051
Drug: CX-2051
Investigational drug
Experimental: CX-2051 + bevacizumab
Drug: Bevacizumab
IV infusion
Other Names:
  • Avastin
Drug: CX-2051
Investigational drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of CX-2051
Time Frame: 44 months
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
44 months
Determine the recommended Phase 2 dose (RP2D)
Time Frame: 44 months
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
44 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 60 months
ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment
60 months
Duration of response (DOR)
Time Frame: 60 months
DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
60 months
Progression-free survival (PFS)
Time Frame: 60 months
PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
60 months
Disease control rate (DCR)
Time Frame: 60 months
DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.
60 months
Duration of disease control (DODC)
Time Frame: 60 months
DODC defined as the time from the first documentation of confirmed CR, PR, or SD (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
60 months
Overall survival (OS)
Time Frame: 60 months
OS defined as the time from the first dose of study intervention to death due to any cause
60 months
Time to Treatment Failure (TTF)
Time Frame: 60 months
TTF defined as the time from first dose of study intervention to the date of premature discontinuation for any reason, including tumor progression, severe toxicity, participant withdrawal, or death.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytomX Therapeutics

Investigators

  • Study Director: Monika Vainorius, MD, CytomX Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMX-2051-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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