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A Study of LY4050784 for Advanced Solid Tumors with SMARCA4 Alteration

This study is testing a new drug called LY4050784, by itself or with other cancer medicines like Pembrolizumab, Cisplatin, Carboplatin, or Pemetrexed. The main goal is to see if LY4050784 is safe, how well people tolerate it, and if it helps treat advanced or metastatic (spread to other parts of the body) solid tumors. You might be able to join if you have a solid tumor with a specific change called a SMARCA4 (BRG1) alteration, and you've already had standard treatments, can't have them, or there are no standard treatments available. The study will also look at how many people respond to the treatment. This study is planned to enroll 340 participants and will last up to about 4 years.

Study design
This is an interventional study with two parts: Phase 1a to find the right dose, and Phase 1b to further test the drug. It aims to enroll 340 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 48 months (4 years) to track side effects and treatment response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06561685

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Eli Lilly and Company
~340 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:LY4050784PembrolizumabCisplatinCarboplatinPemetrexedPaclitaxel

At a glance

Recruiting sites
28 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs)
Measured over Up to Approximately 48 Months or 4 Years
+4 more outcomes measured

Conditions

Metastatic Solid Tumor
Advanced Solid Tumor
Non-small Cell Lung Cancer
SMARCA4-Deficient Tumor

Explore related trials

Lung Non-Small Cell CarcinomaSolid NeoplasmTranscription Activator BRG1

Where it's being run

33 sites across 16 states
Japan5
Tennessee3
France3
Germany3
South Korea3
Colorado2
Florida2
Massachusetts2

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (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 locally advanced and not suitable for definitive locoregional therapy, or metastatic with 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 the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with 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 all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.
Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.
Phase 1b expansion (Part C): Participants may be treatment naïve or have received therapy for advanced or metastatic disease
Measurability of disease
Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion

Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations
Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation)
Participants with known or suspected history of untreated or uncontrolled central nervous 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 to conceive or father children during study or within 6 months after the last dose of study intervention
Participants with history of active autoimmune diseases, history of allogenic stem cell/organ transplant or compromised immune system within past 2 years (Part C only)

What this trial measures

  • Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs)Up to Approximately 48 Months or 4 Years

    A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module

  • Phase 1a: To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LY4050784Up to Approximately 48 Months or 4 Years

    Number of participants with dose-limiting toxicities (DLTs)

  • Phase 1b: To assess the antitumor activity of LY4050784 Monotherapy: Overall response rate (ORR)Up to Approximately 48 Months or 4 Years

    ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  • Phase 1b (Dose optimization only): To confirm the RP2D/optimal dose based on safety and efficacy of LY4050784Up to Approximately 48 Months or 4 Years

    A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module, ORR and Duration of Response (DOR) per Investigator

  • Phase 1b (Combination cohorts/Part C): To assess the safety and tolerability of LY4050784 when administered in combination with other anticancer agentsUp to Approximately 48 Months or 4 Years

    A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module