Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [¹⁴C]-LOXO-783, LY3849524
LOXO-783 · 1 trial · 1 indication
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...
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LOXO-783 is an investigational small molecule being studied for the treatment of breast cancer and other solid tumors. It is being developed by Eli Lilly and Company and is currently in Phase 1 clinical development. It is not yet approved for any indication.
LOXO-783 targets PI3K alpha, specifically the H1047R mutant form of the protein. This mutation is a known oncogenic driver, and LOXO-783 is designed to selectively inhibit the mutant PI3K alpha H1047R protein in tumors that carry this alteration.
LOXO-783 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating LOXO-783 in breast cancer and other solid tumors.
LOXO-783 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is evaluating the drug in patients with breast cancer and other solid tumors.
LOXO-783 is being evaluated in one active clinical trial, NCT05307705, titled A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors. The Phase 1 trial has an enrollment of 260 patients, is currently active but not recruiting, and is being conducted across the United States, Europe, Asia, and Australia.
Yes, [14C]-LOXO-783 is an alternative name for LOXO-783. The carbon-14 labeled form refers to the same investigational compound developed by Eli Lilly and Company, and it is used in the clinical program studying the drug in breast cancer and other solid tumors.