First In Human Study of CX-801 in Advanced Solid Tumors
- Registration Number
- NCT06462794
- Lead Sponsor
- CytomX Therapeutics
- Brief Summary
The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.
- Detailed Description
The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 121
- 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
- Adequate organ function
- 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
- Prior immunotherapy discontinued due to grade 3 or higher immune related adverse event
- Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment
- Investigational drug or device within 4 weeks prior to first dose of study treatment
- Radiation within 2 weeks prior to first dose of study treatment
- Serious concurrent illness
- Pregnant or breast feeding
- Additional exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CX-801 CX-801 - CX-801 + pembrolizumab CX-801 - CX-801 + pembrolizumab pembrolizumab -
- Primary Outcome Measures
Name Time Method Safety and tolerability of CX-801 as monotherapy and combination therapy 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
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
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
Overall survival (OS) 60 months OS defined as the time from the first dose of study intervention to death due to any cause.
Trial Locations
- Locations (2)
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Pittsburgh Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States