A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

Last updated: January 27, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Non-small Cell Lung Cancer

Neoplasms

Treatment

LY4050784

Clinical Study ID

NCT06561685
27191
J5M-OX-JOXA
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have one of the following locally advanced or metastatic solid tumor malignancy withSMARCA4 (BRG1) alteration:

  • Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)

  • Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locallyadvanced and not suitable for definitive locoregional therapy, or metastaticwith presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.

  • Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has thepresence of a known or likely loss of function alteration in SMARCA4 (BRG1) orloss of protein expression.

  • Prior Systemic Therapy Criteria:

  • Phase 1a dose escalation and Phase 1b (Part B): Participants who received allstandard therapies for which the individual was deemed to be an appropriatecandidate by the treating Investigator; or the individual is refusing theremaining most appropriate standard of care treatment; or there is no standardtherapy available for the disease.

  • Phase 1b expansion (Part A): Participants must have received at least one lineof therapy for advanced or metastatic disease.

  • Measurability of disease

  • Phase 1a dose escalation (excluding backfill): measurable or non-measurabledisease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECISTv1.1)

  • Phase 1a backfill and Phase 1b expansion: Measurable disease required asdefined by RECIST v1.1

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion

Exclusion Criteria:

  • Participants with known loss of function alteration of SMARCA2 (BRM) or malignancywith known association with SMARCA2 (BRM) alterations

  • Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure maybe permitted for dose escalation)

  • Participants with known or suspected history of untreated or uncontrolled centralnervous system (CNS) involvement

  • Participants with history of increased risk of prolonged QT or significant arrythmia

  • Significant cardiovascular disease

  • Participants with active or recently treated (within 2 years) second primarymalignancy and/or treated for an additional malignancy within 2 years prior toenrolment

  • Participants who are pregnant, breastfeeding or plan to breastfeed or expecting toconceive or father children during study or within 6 months after the last dose ofstudy intervention

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: LY4050784
Phase: 1
Study Start date:
September 19, 2024
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • Aichi Cancer Center Hospital

    Nagoya, Aichi 464-8681
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto City, Tokyo 135-8550
    Japan

    Active - Recruiting

  • UCLA

    Santa Monica, California 90404
    United States

    Site Not Available

  • University of Colorado Health Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Sarah Cannon Research Institute at HealthOne

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Florida Cancer Specialists ORLANDO/DDU

    Lake Mary, Florida 32746
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • The University of Illinois at Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Ohio State University Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232-6307
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Active - Recruiting

  • USO-Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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