A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

Last updated: February 3, 2025
Sponsor: Chugai Pharmaceutical
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Cetuximab

LUNA18

Clinical Study ID

NCT05012618
LUN101JG
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 1 dose-escalation and cohort expansion study that will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of LUNA18 when administered as a single agent or in combination with other anti-cancer drugs in patients with locally advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >= 18 years at time of signing informed consent form

  • ECOG performance status of 0 or 1

  • Patients with a histologically or cytologically proven diagnosis of a locallyadvanced, recurrent, or metastatic incurable solid tumor for which standard therapyeither does not exist or has proven ineffective or intolerable

  • Patients with documented RAS alterations positive solid tumors

  • Patients with measurable disease per RECIST v1.1

Exclusion

Exclusion Criteria:

  • Significant cardiovascular disease, such as New York Heart Association (NYHA)cardiac disease (Class II or greater), unstable angina, or myocardial infarctionwithin the previous 6 months or unstable arrhythmias within the previous 3 months

  • Patients with primary central nervous system (CNS) malignancy, untreated CNSmetastases requiring any anti-tumor treatment, or active CNS metastases

  • Patients with current severe, uncontrolled systemic disease (including, but notlimited to, clinically significant cardiovascular disease, pulmonary disease, orrenal disease, ongoing or active infection)

  • Patients with a history or complication of interstitial lung disease (ILD)

Study Design

Total Participants: 195
Treatment Group(s): 2
Primary Treatment: Cetuximab
Phase: 1
Study Start date:
October 08, 2021
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Aichi Cancer Center

    Nagoya, Aichi 464-8681
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi, Shizuoka 411-0934
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • University of California - Davis

    Davis, California 95616
    United States

    Active - Recruiting

  • Beth Israel Deaconess

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Midwest

    Grand Rapids, Michigan 49546
    United States

    Terminated

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania 19106
    United States

    Active - Recruiting

  • Rhode Island Hospital-Comprehensive Cancer Center

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • NEXT Oncology

    Austin, Texas 78758
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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