Clinical trial NCT06462794: First In Human Study of CX-801 in Advanced Solid Tumors
Official title: An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: CytomX Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-06-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability of CX-801 as monotherapy and combination therapy
timeFrame: 44 months
measure: Determine the recommended Phase 2 dose (RP2D)
timeFrame: 44 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 60 months
measure: Duration of response (DOR)
timeFrame: 60 months
measure: Progression-free survival (PFS)
timeFrame: 60 months
measure: Disease control rate (DCR)
timeFrame: 60 months
measure: Duration of disease control (DODC)
timeFrame: 60 months
measure: Overall survival (OS)
timeFrame: 60 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Pittsburgh
country: United States
facility: University of Pittsburgh Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: CytomX Therapeutics
name: Monika Vainorius, MD
role: STUDY_DIRECTOR
References: