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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LY4050784 — DRUG
  Oral
• Pembrolizumab — DRUG
  Administered IV.
• Cisplatin — DRUG
  Administered IV.
• Carboplatin — DRUG
  Administered IV.
• Pemetrexed — DRUG
  Administered IV.
• Paclitaxel — DRUG
  Administered IV.
• Nab paclitaxel — DRUG
  Administered IV.

Study Details

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.

Key Dates

Start date

Sep 19, 2024

Status verified

Apr 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

340 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LY4050784 (Phase 1a - Dose Escalation)
  Escalating doses of LY4050784 administered orally.
• Experimental: LY4050784 (Phase 1b - Dose Optimization/Part A)
  Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally.
• Experimental: LY4050784 (Phase 1b - Dose Expansion/Part B)
  LY4050784 administered orally.
• Experimental: LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1
  LY4050784 administered orally in combination in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
• Experimental: LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a
  LY4050784 administered orally in combination in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
• Experimental: LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b
  LY4050784 administered orally in combination in combination with pembrolizumab, paclitaxel/nab-paclitaxel and carboplatin administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Primary Outcome Measure

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 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (17)

Find similar trials in Santa Monica, CA

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