A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

JRCT ID: jRCT2051240129

Registered date:18/09/2024

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Metastatic Solid Tumor
Advanced Solid Tumor
Non-small Cell Lung Cancer
SMARCA4-Deficient Tumor

• Date of first enrollment: 18/09/2024
• Target sample size: 160
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

DRUG: LY4050784
Oral

[Study Arms]
Experimental: LY4050784 (Phase 1a - Dose Escalation)
Escalating doses of LY4050784 administered orally.
Interventions:
Drug: LY4050784
Experimental: LY4050784 (Phase 1b - Dose Optimization/Part A)
Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally.
Interventions:
Drug: LY4050784
Experimental: LY4050784 (Phase 1b - Dose Expansion/Part B)
LY4050784 administered orally.
Interventions:
Drug: LY4050784

Outcome(s)

Primary Outcome

Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) [ Time Frame: Up to Approximately 48 Months or 4 Years
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Have one of the following locally advanced or metastatic solid tumor malignancy with BRG1/SMARCA4 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.
- 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.
- 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

Exclude criteria

- Participants with known 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 or recently treated (within 2 years) second primary malignancy and/or treated for an additional 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

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06561685