A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

Last updated: July 29, 2024
Sponsor: Chugai Pharmaceutical
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

SPYK04

Clinical Study ID

NCT04511845
SPK101JG
  • Ages > 18
  • All Genders

Study Summary

Phase I, open-label, multi-center study

Eligibility Criteria

Inclusion

Inclusion Criteria:

(Both Part I and Part II)

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

  • ECOG performance status of 0 or 1

  • Patients with a locally advanced, recurrent, or metastatic solid tumor for whichstandard therapy either does not exist or has proven ineffective or intolerable

(Part I only)

  • Patients with measurable and/or evaluable disease per RECIST v1.1

  • Patients with MAPK pathway alterations positive solid tumor (i.e., BRAF, K/N/H-RASmutations)

(Part II only)

  • Patients with measurable disease per RECIST v1.1

  • Patients with KRAS mutated NSCLC (NSCLC cohort)

  • Patients with KRAS mutated Ovarian Cancer (Ovarian Cancer cohort)

  • Patients with RAS mutated solid tumor (Biopsy cohort)

Exclusion

Exclusion Criteria:

(Both Part I and Part II)

  • 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: 113
Treatment Group(s): 1
Primary Treatment: SPYK04
Phase: 1
Study Start date:
September 10, 2020
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume, Fukuoka 830-0011
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-Ku, Tokyo 135-8550
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Site Not Available

  • Osaka Prefectural Hospital Organization Osaka International Cancer Center

    Osaka, 541-8567
    Japan

    Site Not Available

  • Arizona Oncology

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • Minnesota Oncology

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Oncology

    Tyler, Texas 75702
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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