Actively Recruiting
An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations
Led by Eli Lilly and Company · Updated on 2026-04-20
340
Participants Needed
33
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of the study drug LY4050784 alone or combined with other anticancer agents in adults with locally advanced or metastatic solid tumors that have a SMARCA4 (also called BRG1) gene alteration. This study includes participants who have previously received, do not qualify for, or refuse standard treatments, or when no standard therapy exists. The trial is conducted in two parts: phase Ia for dose escalation and phase Ib for dose optimization and expansion, lasting up to about 4 years. The study involves oral administration of LY4050784 in escalating doses or fixed doses, either alone or combined with intravenous anticancer drugs such as pembrolizumab, pemetrexed, cisplatin, carboplatin, paclitaxel, or nab-paclitaxel. Treatments are given in 21-day cycles, and participants may continue until specific discontinuation criteria are met. Different groups receive either LY4050784 alone or in combination with these agents, with careful dose evaluation during phase Ia and expansion in phase Ib. Participants will undergo regular assessments to monitor safety, including tracking any adverse events and determining the maximum tolerated dose. Researchers will measure how the drug is processed in the body, antitumor activity through response rates and disease control, and overall treatment effects over up to 4 years. Evaluations include physical exams, imaging scans, laboratory tests, and performance status checks. The study also monitors tolerability and long-term effects during treatment and follow-up periods.
CONDITIONS
Brief Title
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with locally advanced or metastatic solid tumors that have SMARCA4 (BRG1) alterations
- For phase 1a dose escalation: any alteration in SMARCA4 (BRG1)
- For phase 1b expansion Part A: Non-small Cell Lung Cancer (NSCLC) with SMARCA4 loss or protein expression loss, not suitable for locoregional therapy
- For phase 1b expansion Part B: any tumor type (excluding NSCLC) with SMARCA4 loss or protein expression loss
- For phase 1b expansion Part C: NSCLC with SMARCA4 loss or protein expression loss, treatment naive or previously treated
- Prior systemic therapy: participants must have received all standard therapies, be refusing remaining standard care, or have no standard therapy available (phase 1a and part B)
- Participants in Part A must have received at least one therapy line for advanced disease
- Measurable disease per RECIST v1.1 (phase 1a backfill and phase 1b) or measurable or non-measurable disease (phase 1a dose escalation excluding backfill)
- ECOG performance status of 0 or 1
You will not qualify if you...
- Known or suspected loss of function alteration in SMARCA2 (BRM) or related malignancies
- Prior exposure to SMARCA2 (BRM) inhibitors or degraders (except allowed in dose escalation)
- Untreated or uncontrolled central nervous system involvement
- History of prolonged QT interval or significant arrhythmia
- Significant cardiovascular disease
- Active or treated other primary malignancy within 2 years before enrollment
- Pregnant, breastfeeding, planning to conceive or father children during or within 6 months after treatment
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 48 months or 4 years
Participants receive LY4050784 orally, alone or in combination with other anticancer drugs administered intravenously in 21-day cycles. Treatment continues until discontinuation criteria are met.
Repeated 21-day cycles with multiple visits per cycle for treatment administration and monitoring
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
P
Physicians interested in becoming principal investigators please 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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