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RecruitingInterventionalPhase 1

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

NCT ID: NCT06265688Sponsor: CytomX TherapeuticsLast updated: 2026-05-19

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.

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.

Arms & interventions

  • DrugCX-2051

    Investigational drug

  • DrugBevacizumab

    IV infusion

Outcome measures

Primary

  • 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

    Time frame: 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

    Time frame: 44 months

Secondary

  • Objective response rate (ORR)

    Time frame: 60 months

  • Duration of response (DOR)

    Time frame: 60 months

  • Progression-free survival (PFS)

    Time frame: 60 months

  • Time to Treatment Failure (TTF)

    Time frame: 60 months

  • Disease control rate (DCR)

    Time frame: 60 months

  • Duration of disease control (DODC)

    Time frame: 60 months

  • Overall survival (OS)

    Time frame: 60 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (7)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218

Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Montefiore Medical Center

The Bronx, New York, 10461

Recruiting

Carolina BioOncology Institute, PLLC

Huntersville, North Carolina, 28078

Recruiting

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, 37203

Recruiting

START San Antonio LLC

San Antonio, Texas, 78229

Recruiting

NEXT Virginia

Fairfax, Virginia, 22031

Recruiting