Solid Tumor, Adult
Conditions
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.
Interventions
DRUGCX-801
Investigational drug
DRUGpembrolizumab
Standard of Care Therapy
Sponsors
CytomX Therapeutics
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Adequate organ function * 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 * Prior PD-1/ PD-(L)1 inhibitor treatment 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTKaren Deane
STUDY_DIRECTORMonika Vainorius, MD
CytomX Therapeutics
Outcome results
None listed