First In Human Study of CX-2051 in Advanced Solid Tumors
- Registration Number
- NCT06265688
- Lead Sponsor
- CytomX Therapeutics
- 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 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. Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 in indication-specific expansion cohorts.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CX-2051 CX-2051 -
- Primary Outcome Measures
Name Time Method Determine the recommended Phase 2 dose (RP2D) 44 months 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
Safety and tolerability of CX-2051 44 months 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
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) 60 months DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Disease control rate (DCR) 60 months DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.
Overall survival (OS) 60 months OS defined as the time from the first dose of study intervention to death due to any cause
Objective response rate (ORR) 60 months ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment
Progression-free survival (PFS) 60 months PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Duration of disease control (DODC) 60 months DODC defined as the time from the first documentation of confirmed CR, PR, or SD (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Trial Locations
- Locations (4)
Sarah Cannon Research Institute at HealthONE
🇺🇸Denver, Colorado, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Carolina BioOncology Institute, PLLC
🇺🇸Huntersville, North Carolina, United States
Sarah Cannon Research Institute, LLC
🇺🇸Nashville, Tennessee, United States