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New treatment option for Metastatic Solid Tumor
Official title A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06561685
What this study is testing
What is LY4050784?
LY4050784 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Lake Mary, Florida, United States
- Miami, Florida, United States
- New Lenox, Illinois, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Milwaukee, Wisconsin, United States
- Bordeaux, France
- Paris, France
- Villejuif, France
- Berlin, Germany
- Essen, Germany
- Frankfurt am Main, Germany
- Chūōku, Japan
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; Lake Mary, Florida, United States; Miami, Florida, United States; New Lenox, Illinois, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.