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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05307705 | A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 193 | — | — | May 11, 2022 | Dec 1, 2026 | Apr 20, 2026 | 50 | United States, Australia +10 |
Number of patients with DLTs
Number of patients with DLT-equivalent toxicities
| Arm | Type | Description |
|---|---|---|
| Phase 1A: LOXO-783 Monotherapy Dose Escalation | EXPERIMENTAL | LOXO-783 administered orally |
| Phase 1B: Part A | EXPERIMENTAL | LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally |
| Phase 1B: Part B | EXPERIMENTAL | LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally |
| Phase 1B: Part C | EXPERIMENTAL | LOXO-783 orally in combination with fulvestrant intramuscularly |
| Phase 1B: Part D | EXPERIMENTAL | LOXO-783 orally in combination with paclitaxel intravenously |
| Phase 1B: Part E | EXPERIMENTAL | LOXO-783 orally |
| Phase 1B: Part F | EXPERIMENTAL | Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly |
| Name | Type | Description |
|---|---|---|
| LOXO-783 | DRUG | Oral |
| Fulvestrant | DRUG | Intramuscular |
| Imlunestrant | DRUG | Oral |
| Abemaciclib | DRUG | Oral |
| Anastrozole, Exemestane, or Letrozole | DRUG | Oral |
| Paclitaxel | DRUG | Intravenous |
Inclusion Criteria: * Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation) * Have...