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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06462794
Other study ID # CTMX-801-101
Secondary ID KEYNOTE-F95MK-34
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 30, 2024
Est. completion date June 30, 2029

Study information

Verified date June 2024
Source CytomX Therapeutics
Contact Karen Deane
Phone 650-515-3185
Email clinicaltrials@cytomx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 121
Est. completion date June 30, 2029
Est. primary completion date February 28, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
CX-801
Investigational drug
pembrolizumab
Standard of Care Therapy

Locations

Country Name City State
United States University of Pittsburgh Hillman Cancer Center Pittsburgh Pennsylvania
United States University of California San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
CytomX Therapeutics Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of CX-801 as monotherapy and combination therapy 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 44 months
Primary Determine the recommended Phase 2 dose (RP2D) 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 44 months
Secondary Objective response rate (ORR) 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. 60 months
Secondary Duration of response (DOR) 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. 60 months
Secondary Progression-free survival (PFS) 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. 60 months
Secondary Disease control rate (DCR) DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment. 60 months
Secondary Duration of disease control (DODC) 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. 60 months
Secondary Overall survival (OS) OS defined as the time from the first dose of study intervention to death due to any cause. 60 months
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