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RecruitingInterventionalPhase 1

An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors

NCT ID: NCT06462794Sponsor: CytomX TherapeuticsLast updated: 2026-05-15

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.

Arms & interventions

  • DrugCX-801

    Investigational drug

  • Drugpembrolizumab

    Standard of Care Therapy

Outcome measures

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

    Time frame: 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

    Time frame: 44 months

Secondary

  • Objective response rate (ORR)

    Time frame: 60 months

  • Duration of response (DOR)

    Time frame: 60 months

  • Progression-free survival (PFS)

    Time frame: 60 months

  • Disease control rate (DCR)

    Time frame: 60 months

  • Duration of disease control (DODC)

    Time frame: 60 months

  • Overall survival (OS)

    Time frame: 60 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 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 * Additional exclusion criteria may apply

Study locations (3)

The Melanoma and Skin Cancer Institute

Englewood, Colorado, 80113

Recruiting

University of Pittsburgh Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

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