NCT06265688

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1

Timeline
35mo left

Started Apr 2024

Longer than P75 for phase_1

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Apr 2024Mar 2029

First Submitted

Initial submission to the registry

February 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 2, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

3.7 years

First QC Date

February 12, 2024

Last Update Submit

May 15, 2026

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability of CX-2051

    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)

    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 Outcomes (7)

  • Objective response rate (ORR)

    60 months

  • Duration of response (DOR)

    60 months

  • Progression-free survival (PFS)

    60 months

  • Time to Treatment Failure (TTF)

    60 months

  • Disease control rate (DCR)

    60 months

  • +2 more secondary outcomes

Study Arms (2)

CX-2051

EXPERIMENTAL
Drug: CX-2051

CX-2051 + bevacizumab

EXPERIMENTAL
Drug: CX-2051Drug: Bevacizumab

Interventions

CX-2051DRUG

Investigational drug

CX-2051CX-2051 + bevacizumab
BevacizumabDRUG

IV infusion

Also known as: Avastin
CX-2051 + bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Carolina BioOncology Institute, PLLC

Huntersville, North Carolina, 28078, United States

RECRUITING

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, 37203, United States

RECRUITING

START San Antonio LLC

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Monika Vainorius, MD

    CytomX Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Karen Deane

CONTACT

650-515-3185clinicaltrials@cytomx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 20, 2024

Study Start

April 2, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

March 31, 2029

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations

US(7)