A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
NCT ID: NCT06561685
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
340 participants
INTERVENTIONAL
2024-09-19
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LY4050784 (Phase 1a - Dose Escalation)
Escalating doses of LY4050784 administered orally.
LY4050784
Oral
LY4050784 (Phase 1b - Dose Optimization/Part A)
Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally.
LY4050784
Oral
LY4050784 (Phase 1b - Dose Expansion/Part B)
LY4050784 administered orally.
LY4050784
Oral
LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1
LY4050784 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
Oral
Pembrolizumab
Administered IV.
LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a
LY4050784 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
Oral
Pembrolizumab
Administered IV.
Cisplatin
Administered IV.
Carboplatin
Administered IV.
Pemetrexed
Administered IV.
LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b
LY4050784 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.
LY4050784
Oral
Pembrolizumab
Administered IV.
Carboplatin
Administered IV.
Paclitaxel
Administered IV.
Nab paclitaxel
Administered IV.
Interventions
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LY4050784
Oral
Pembrolizumab
Administered IV.
Cisplatin
Administered IV.
Carboplatin
Administered IV.
Pemetrexed
Administered IV.
Paclitaxel
Administered IV.
Nab paclitaxel
Administered IV.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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UCLA
Santa Monica, California, United States
University of Colorado Health Hospital
Aurora, Colorado, United States
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida, United States
University of Miami
Miami, Florida, United States
University of Chicago
New Lenox, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Ohio State University Hospital
Columbus, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
National Cancer Center Hospital
Chūōku, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
The Cancer Institute Hospital of JFCR
Kōtō City, , Japan
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Related Links
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A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Other Identifiers
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J5M-OX-JOXA
Identifier Type: OTHER
Identifier Source: secondary_id
27191
Identifier Type: -
Identifier Source: org_study_id