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LY4050784

Phase 1

Metastatic Solid Tumor | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Aug 7, 2026

Target and mechanism

Molecular targetSMARCA2
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment340

FDA Designations

No designations recorded

Clinical trial landscape

LY4050784 · 1 trial · 4 indications

Phase 1 1
NCT06561685A Study of LY4050784 in Participants With Advanced or Metastatic Solid TumorsMetastatic Solid Tumor
RECRUITING340 Analytics
PHASE1RECRUITING
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Metastatic Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

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 LY4050784
Up 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 LY4050784
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

Phase 1b (Combination cohorts/Part C): To assess the safety and tolerability of LY4050784 when administered in combination with other anticancer agents
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 Endpoints

To characterize the pharmacokinetics (PK) properties of LY4050784: Maximum Concentration (Cmax)
Cycle 1 (Day 8)
To characterize the PK properties of LY4050784: Time to Maximum Concentration (Tmax)
Cycle 1 (Day 8)
To characterize the PK properties of LY4050784: Area under the concentration versus time curve (AUC)
Cycle 1 (Day 8)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY4050784 (Phase 1a - Dose Escalation)EXPERIMENTALEscalating doses of LY4050784 administered orally.
LY4050784 (Phase 1b - Dose Optimization/Part A)EXPERIMENTALComparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally.
LY4050784 (Phase 1b - Dose Expansion/Part B)EXPERIMENTALLY4050784 administered orally.
LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1EXPERIMENTALLY4050784 administered orally in combination in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2aEXPERIMENTALLY4050784 administered orally in combination in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2bEXPERIMENTALLY4050784 administered orally in combination in combination with pembrolizumab, paclitaxel/nab-paclitaxel and carboplatin administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Interventions

NameTypeDescription
LY4050784DRUGOral
PembrolizumabDRUGAdministered IV.
CisplatinDRUGAdministered IV.
CarboplatinDRUGAdministered IV.
PemetrexedDRUGAdministered IV.
PaclitaxelDRUGAdministered IV.
Nab paclitaxelDRUGAdministered IV.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

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 advanc...

Countries:United StatesFranceGermanyJapanSouth KoreaSpain
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Metastatic Solid Tumor")

Recent Changes (Last 90 Days)

LOWAug 7, 2026NCT06561685lastUpdatePostDate: changed
LOWAug 7, 2026NCT06561685lastUpdatePostDate: changed

Frequently asked questions about LY4050784

What is LY4050784 used for?

LY4050784 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors, including non-small cell lung cancer and SMARCA4-deficient tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does LY4050784 target?

LY4050784 targets SMARCA2, a protein involved in chromatin remodeling. By inhibiting SMARCA2, the drug aims to disrupt tumor cell growth in cancers that may depend on this protein, particularly those with SMARCA4 deficiency.

Who is developing LY4050784?

LY4050784 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical trials for advanced or metastatic solid tumors.

What phase is LY4050784 in?

LY4050784 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants to evaluate the drug's safety and efficacy.

What clinical trials is LY4050784 in?

LY4050784 is being studied in a single Phase 1 clinical trial with the identifier NCT06561685. This trial is recruiting participants with advanced or metastatic solid tumors, including non-small cell lung cancer and SMARCA4-deficient tumors, across multiple countries including the United States, France, Germany, Japan, South Korea, and Spain.

Is LY4050784 the same as any other drug?

LY4050784 is the primary name for this investigational drug. No alternative names have been reported for this compound in clinical development.