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First In Human Study of CX-2051 in Advanced Solid Tumors
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06265688.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
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.
