Informations générales (source: ClinicalTrials.gov)
An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations
Interventional
Phase 1
Eli Lilly and Company (Voir sur ClinicalTrials)
septembre 2024
octobre 2027
02 mars 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Rastilav BAHLEDA | 03/07/2026 13:40:05 | Contacter | ||
Critères
Tous
- 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 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:
- 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)