First In Human Study of CX-801 in Advanced Solid Tumors

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

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
• 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
• 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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

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