Actively Recruiting
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Led by Eli Lilly and Company · Updated on 2026-04-20
340
Participants Needed
33
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration
- Phase 1a: Any alteration in SMARCA4 (BRG1)
- Phase 1b Part A: Non-small Cell Lung Cancer (NSCLC) locally advanced or metastatic with loss of function alteration or loss of protein expression in SMARCA4 (BRG1)
- Phase 1b Part B: Any tumor type other than NSCLC with loss of function alteration or loss of protein expression in SMARCA4 (BRG1)
- Phase 1b Part C: NSCLC locally advanced or metastatic with loss of function alteration or loss of protein expression in SMARCA4 (BRG1)
- Phase 1a and Phase 1b Part B: Received all standard therapies, or refusing remaining standard care, or no standard therapy available
- Phase 1b Part A: Received at least one line of therapy for advanced or metastatic disease
- Phase 1b Part C: May be treatment naive or have received therapy for advanced or metastatic disease
- Measurable or non-measurable disease per RECIST v1.1 for Phase 1a dose escalation (excluding backfill)
- Measurable disease per RECIST v1.1 for Phase 1a backfill and Phase 1b expansion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Known or likely loss of function alteration of SMARCA2 (BRM) or malignancy associated with SMARCA2 (BRM) alterations
- Prior exposure to SMARCA2 (BRM) inhibitors or degraders (except permitted in dose escalation)
- Known or suspected untreated or uncontrolled central nervous system involvement
- History of increased risk of prolonged QT or significant arrhythmia
- Significant cardiovascular disease
- Active or treated additional primary malignancy within 2 years before enrollment
- Pregnant, breastfeeding, planning to breastfeed, or expecting to conceive or father children during study or within 6 months after last dose
- History of active autoimmune diseases, allogenic stem cell or organ transplant, or compromised immune system within past 2 years (Part C only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
UCLA
Santa Monica, California, United States, 90404
Actively Recruiting
2
University of Colorado Health Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States, 80218
Actively Recruiting
4
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida, United States, 32746
Active, Not Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
University of Chicago
New Lenox, Illinois, United States, 60451
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
11
Ohio State University Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6307
Actively Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Actively Recruiting
16
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
17
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
18
Institut Bergonie
Bordeaux, France, 33 076
Not Yet Recruiting
19
Institut Curie
Paris, France, 75248
Actively Recruiting
20
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, France, 94800
Not Yet Recruiting
21
Charite-Universitatsmedizin Berlin
Berlin, Germany, 10117
Not Yet Recruiting
22
Universitaetsklinikum Essen
Essen, Germany, 45147
Not Yet Recruiting
23
Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488
Not Yet Recruiting
24
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
25
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
26
The Cancer Institute Hospital of JFCR
Kōtō City, Japan, 135-8550
Actively Recruiting
27
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, Japan, 411-8777
Actively Recruiting
28
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Actively Recruiting
29
National Cancer Center
Ilsandong-gu, South Korea, 10408
Not Yet Recruiting
30
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
31
The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea, 16247
Actively Recruiting
32
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
33
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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