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NCT Number: NCT06462794

First In Human Study of CX-801 in Advanced 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.

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Key information

Conditions

Solid Tumor, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Melanoma and Skin Cancer Institute, Englewood, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CX-801

Drug

Investigational drug

Pembrolizumab

Drug

Standard of Care Therapy

Other names: KEYTRUDA®

Primary outcomes

  1. Safety and tolerability of CX-801 as monotherapy and combination therapy

    Time frame: 44 months

    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

  2. Determine the recommended Phase 2 dose (RP2D)

    Time frame: 44 months

    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

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: 60 months

    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.

  2. Duration of response (DOR)

    Time frame: 60 months

    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.

  3. Progression-free survival (PFS)

    Time frame: 60 months

    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.

  4. Disease control rate (DCR)

    Time frame: 60 months

    DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.

  5. Duration of disease control (DODC)

    Time frame: 60 months

    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.

  6. Overall survival (OS)

    Time frame: 60 months

    OS defined as the time from the first dose of study intervention to death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Deane

CONTACT

[email protected]

650-515-3185

Sponsors and collaborators

Lead sponsor

CytomX Therapeutics

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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