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

NCT06462794 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: CTMX-801-101KEYNOTE-F95MK-3475-F95
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 3

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.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Objective response rate (ORR)

  60 months

• Duration of response (DOR)

  60 months

• Progression-free survival (PFS)

  60 months

• Disease control rate (DCR)

  60 months

• Duration of disease control (DODC)

  60 months

Study Arms (2)

CX-801

EXPERIMENTAL

Drug: CX-801

CX-801 + pembrolizumab

EXPERIMENTAL

Drug: CX-801; Drug: pembrolizumab

Interventions

CX-801 DRUG

Investigational drug

CX-801; CX-801 + pembrolizumab

pembrolizumab DRUG

Standard of Care Therapy

Also known as: KEYTRUDA®

CX-801 + pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CytomX Therapeutics: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

The Melanoma and Skin Cancer Institute

Englewood, Colorado, 80113, United States

RECRUITING

University of Pittsburgh Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Monika Vainorius, MD

  CytomX Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Karen Deane

CONTACT

650-515-3185; clinicaltrials@cytomx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (3)