Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06561685 | A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | 340 | — | — | Sep 19, 2024 | Oct 1, 2027 | Apr 20, 2026 | 33 | United States, France +4 |
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Number of participants with dose-limiting toxicities (DLTs)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module, ORR and Duration of Response (DOR) per Investigator
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| LY4050784 (Phase 1a - Dose Escalation) | EXPERIMENTAL | Escalating doses of LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Optimization/Part A) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Expansion/Part B) | EXPERIMENTAL | LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1 | EXPERIMENTAL | 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. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a | EXPERIMENTAL | 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. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion 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 advanc...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |