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

Last updated: February 9, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Adenocarcinoma

Neoplasm Metastasis

Neoplasms

Treatment

Carboplatin

Paclitaxel

Pemetrexed

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 alone or in combination with other anticancer agents. In addition, 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.

  • Phase 1b expansion: Part C: 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.

  • 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.

  • Phase 1b expansion (Part C): Participants may be treatment naïve or havereceived 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 or likely loss of function alteration of SMARCA2 (BRM) ormalignancy with 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 and/or treated for an additional primary malignancy within 2 years prior to enrolment

  • 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

  • Participants with history of active autoimmune diseases, history of allogenic stemcell/organ transplant or compromised immune system within past 2 years (Part C only)

Study Design

Total Participants: 340
Treatment Group(s): 7
Primary Treatment: Carboplatin
Phase: 1
Study Start date:
September 19, 2024
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • Institut Bergonie

    Bordeaux 3031582, 33 076
    France

    Site Not Available

  • Institut Curie

    Paris 2988507, 75248
    France

    Active - Recruiting

  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

    Villejuif 2968705, 94800
    France

    Site Not Available

  • Charite-Universitatsmedizin Berlin

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Krankenhaus Nordwest

    Frankfurt am Main 2925533, 60488
    Germany

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, 104-0045
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chūōku 10262791, 104-0045
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa 1859924, 277-8577
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto City, 135-8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Kōtō City 11209896, 135-8550
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

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

    Active - Recruiting

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681
    Japan

    Site Not Available

  • Aichi Cancer Center Hospital

    Nagoya 1856057, 464-8681
    Japan

    Active - Recruiting

  • National Cancer Center

    Ilsandong-gu, 10408
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon 1835553, 16247
    South Korea

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • UCLA

    Santa Monica, California 90404
    United States

    Site Not Available

  • UCLA

    Santa Monica 5393212, California 5332921 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

    Site Not Available

  • University of Colorado Health Hospital

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Sarah Cannon Research Institute at HealthOne

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Florida Cancer Specialists ORLANDO/DDU

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Florida Cancer Specialists ORLANDO/DDU

    Lake Mary 4161373, Florida 4155751 32746
    United States

    Active - Recruiting

  • University of Miami

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • The University of Illinois at Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • The University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • The University of Illinois at Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • University of Chicago

    New Lenox 4903535, Illinois 4896861 60451
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Ohio State University Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Ohio State University Hospital

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232-6307
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville 4644585, Tennessee 4662168 37232-6307
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030-4009
    United States

    Active - Recruiting

  • USO-Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • USO-Virginia Cancer Specialists, PC

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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