First In Human Study of CX-2051 in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CX-2051, Bevacizumab.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors
Overview
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.
Interventions
- Drug CX-2051
Investigational drug - Drug Bevacizumab
IV infusion
Primary outcome measures
- Safety and tolerability of CX-2051 [Time frame: 44 months]
- Determine the recommended Phase 2 dose (RP2D) [Time frame: 44 months]
Secondary outcome measures (7)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- Sarah Cannon Research Institute at HealthONE — Denver
- Dana-Farber Cancer Institute — Boston
- Montefiore Medical Center — The Bronx
- Carolina BioOncology Institute, PLLC — Huntersville
- Sarah Cannon Research Institute, LLC — Nashville
- START - Dallas/Fort Worth — Fort Worth
- START San Antonio LLC — San Antonio
- NEXT Virginia — Fairfax
Identifiers
NCT: NCT06265688 · CTMX-2051-101