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OncoMatch/Clinical Trials/NCT06561685

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

Is NCT06561685 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for metastatic solid tumor.

Phase 1RecruitingEli Lilly and CompanyNCT06561685Data as of May 2026

Treatment: LY4050784 · Pembrolizumab · Cisplatin · Carboplatin · Pemetrexed · Paclitaxel · Nab paclitaxelThe 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: SMARCA4 any alteration

Presence of any alteration in SMARCA4 (BRG1) [Phase 1a dose escalation]

Required: SMARCA4 known or likely loss of function alteration

known or likely loss of function alteration in SMARCA4 (BRG1) [Phase 1b expansion Parts A, B, C]

Required: SMARCA4 loss of protein expression

loss of protein expression [Phase 1b expansion Parts A, B, C]

Excluded: SMARCA2 known or likely loss of function alteration

Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations

Disease stage

Required: Stage III, IV

locally advanced and not suitable for definitive locoregional therapy, or metastatic

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard therapy — advanced or metastatic

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

Must have received: any systemic therapy — advanced or metastatic

Participants must have received at least one line of therapy for advanced or metastatic disease [Phase 1b expansion (Part A)]

Cannot have received: SMARCA2 inhibitor

Exception: prior exposure may be permitted for dose escalation

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

Lab requirements

Cardiac function

No significant cardiovascular disease; no history of increased risk of prolonged QT or significant arrhythmia

Participants with history of increased risk of prolonged QT or significant arrythmia; Significant cardiovascular disease

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UCLA · Santa Monica, California
  • University of Colorado Health Hospital · Aurora, Colorado
  • Sarah Cannon Research Institute at HealthOne · Denver, Colorado
  • Florida Cancer Specialists ORLANDO/DDU · Lake Mary, Florida
  • University of Miami · Miami, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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