Solid Tumor, Adult Clinical Trial
Official title:
An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Hillman Cancer Center | Pittsburgh | Pennsylvania |
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
CytomX Therapeutics | Merck Sharp & Dohme LLC |
United States,
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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