> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ly4050784-in-participants-with-advanced-or-3f50a14b-eb77-4dc3-ab23-92da1f743765 > Record changed: 2026-10-13 # A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors NCT06561685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) Participants 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) Start date 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) Number of sites 33 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Short title** A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Official title** An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Dates **Completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **First posted** 2024-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Registry last updated** 2026-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Primary completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Start date** 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Size and sites **Participants** 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Planned participants** 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Number of sites** 33 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Identifiers **Registry ID** NCT06561685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **ClinicalTrials.gov ID** NCT06561685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Outcomes ### Primary outcomes 1. Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Timeframe: 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 2. Phase 1a: To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LY4050784 Timeframe: Up to Approximately 48 Months or 4 Years Number of participants with dose-limiting toxicities (DLTs) 3. Phase 1b: To assess the antitumor activity of LY4050784 Monotherapy: Overall response rate (ORR) Timeframe: Up to Approximately 48 Months or 4 Years ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) 4. Phase 1b (Dose optimization only): To confirm the RP2D/optimal dose based on safety and efficacy of LY4050784 Timeframe: 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, ORR and Duration of Response (DOR) per Investigator 5. Phase 1b (Combination cohorts/Part C): To assess the safety and tolerability of LY4050784 when administered in combination with other anticancer agents Timeframe: 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 ### Secondary outcomes 1. To characterize the pharmacokinetics (PK) properties of LY4050784: Maximum Concentration (Cmax) Timeframe: Cycle 1 (Day 8) PK: Cmax of LY4050784 2. To characterize the PK properties of LY4050784: Time to Maximum Concentration (Tmax) Timeframe: Cycle 1 (Day 8) PK: Tmax of LY4050784 3. To characterize the PK properties of LY4050784: Area under the concentration versus time curve (AUC) Timeframe: Cycle 1 (Day 8) PK: AUC of LY4050784 4. Phase Ia: To evaluate the preliminary antitumor activity of LY4050784: Overall response rate (ORR) Timeframe: Up to Approximately 48 Months or 4 Years ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) 5. To evaluate the preliminary antitumor activity of LY4050784: Duration of response (DOR) Timeframe: Up to Approximately 48 Months or 4 Years DOR per investigator assessed RECIST 1.1 6. To evaluate the preliminary antitumor activity of LY4050784: Time to response (TTR) Timeframe: Up to Approximately 48 Months or 4 Years TTR per investigator assessed RECIST 1.1 7. To evaluate the preliminary antitumor activity of LY4050784: Disease control rate (DCR) Timeframe: Up to Approximately 48 Months or 4 Years DCR per investigator assessed RECIST 1.1 8. To evaluate the preliminary antitumor activity of LY4050784: Progression free survival (PFS) Timeframe: Up to Approximately 48 Months or 4 Years PFS per investigator assessed RECIST 1.1 9. To evaluate the PK properties of LY4050784 in combination cohorts: Maximum Concentration (Cmax) PK: Cmax of LY4050784 Timeframe: Cycle 1 (Day 8) 10. To evaluate the PK properties of LY4050784 in combination cohorts: Time to Maximum Concentration (Tmax) PK: Tmax of LY4050784 Timeframe: Cycle 1 (Day 8) 11. To evaluate the PK properties of LY4050784 in combination cohorts: Area under the concentration versus time curve (AUC) Timeframe: Cycle 1 (Day 8) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 criteria - 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Sites - UCLASanta Monica, United StatesRecruiting - University of Colorado Health HospitalAurora, United StatesRecruiting - Sarah Cannon Research Institute at HealthOneDenver, United StatesRecruiting - Florida Cancer Specialists ORLANDO/DDULake Mary, United StatesActive, not recruiting - University of MiamiMiami, United StatesRecruiting - University of ChicagoNew Lenox, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Columbia University Medical CenterNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Ohio State University HospitalColumbus, United StatesRecruiting - Sarah Cannon Research InstituteNashville, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - Vanderbilt-Ingram Cancer CenterNashville, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - USO-Virginia Cancer Specialists, PCFairfax, United StatesRecruiting - Medical College of WisconsinMilwaukee, United StatesRecruiting - Institut BergonieBordeaux, FranceNot yet recruiting - Institut CurieParis, FranceRecruiting - Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEPVillejuif, FranceRecruiting - Charite-Universitatsmedizin BerlinBerlin, GermanyRecruiting - Universitaetsklinikum EssenEssen, GermanyNot yet recruiting - Krankenhaus NordwestFrankfurt am Main, GermanyNot yet recruiting - National Cancer Center HospitalChūōku, JapanRecruiting - National Cancer Center Hospital EastKashiwa, JapanRecruiting And 8 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/528616) ### Other registry identifiers - J5M-OX-JOXA Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06561685) ## Related records ### Drugs (5) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (4) - [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Squamous cell carcinoma](https://trialight.com/data/condition/squamous-cell-carcinoma-44944de3-3c1f-5714-9da2-a28db7d896c2.md) ### Targets (19) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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