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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCytomX Therapeutics

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CX-2051
  • Bevacizumab

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

7
Colorado
Sarah Cannon Research Institute at HealthONE80218, Denver United States
Massachusetts
Dana-Farber Cancer Institute02215, Boston United States
New York
Montefiore Medical Center10461, The Bronx United States
North Carolina
Carolina BioOncology Institute, PLLC28078, Huntersville United States

Sponsors and collaborators

CytomX Therapeutics

Lead sponsor