Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LOXO-783 · 4 trials · 2 indications
PK: Feur
PK: Fefeces
PK: Feair
PK: F of LOXO-783
PK: Cmax of LOXO-783
PK: AUC \[0-∞\] of LOXO-783
PK: AUC(0-inf) of LOXO-783
Number of patients with DLTs
Number of patients with DLT-equivalent toxicities
| Arm | Type | Description |
|---|---|---|
| [¹⁴C]-LOXO-783 (Part 1) | EXPERIMENTAL | Single dose of \[¹⁴C\]-LOXO-783 administered orally |
| LOXO-783 + [¹⁴C]-LOXO-783 (Part 2) | EXPERIMENTAL | Single dose of LOXO-783 administered orally followed by single dose of \[¹⁴C\]-LOXO-783 administered intravenously (IV) |
| LOXO-783 (Fasted State) | EXPERIMENTAL | LOXO-783 administered orally to participants who are in fasted state |
| LOXO-783 (Fed State - Low Fat Meal) | EXPERIMENTAL | LOXO-783 administered orally to participants who are on low fat meal |
| LOXO-783 (Fed State - High Fat Meal) | EXPERIMENTAL | LOXO-783 administered orally to participants who are on high fat meal |
| LOXO-783 alone | EXPERIMENTAL | Single dose of LOXO-783 administered orally. |
| LOXO-783 + Cholestyramine 1 hour post dose | EXPERIMENTAL | Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 1 hour. |
| LOXO-783 + Cholestyramine 4 hours post dose | EXPERIMENTAL | Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 4 hours. |
| 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 |
|---|---|---|
| [¹⁴C]-LOXO-783 | DRUG | Administered orally |
| LOXO-783 | DRUG | Administered orally |
| Cholestyramine | DRUG | Administered orally. |
| Fulvestrant | DRUG | Intramuscular |
| Imlunestrant | DRUG | Oral |
| Abemaciclib | DRUG | Oral |
| Anastrozole, Exemestane, or Letrozole | DRUG | Oral |
| Paclitaxel | DRUG | Intravenous |
Inclusion Criteria: * Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator * Have a body mass index within the range 18.5 to 32...
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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 currently in Phase 1 clinical development, with an active trial enrolling patients with breast cancer. The drug is not yet approved and remains under investigation for safety and efficacy.
LOXO-783 targets the PI3Kα H1047R mutation, a specific alteration in the PI3Kα protein. This molecular target is relevant in oncology, as the mutation can drive tumor growth. By targeting this specific form of PI3Kα, LOXO-783 aims to interfere with cancer cell signaling pathways.
LOXO-783 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in patients with breast cancer and other solid tumors.
LOXO-783 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The active Phase 1 trial is recruiting participants with breast cancer to assess the drug's safety, tolerability, and pharmacokinetics.
LOXO-783 is being studied in several clinical trials. The main active trial is NCT05307705, a Phase 1 study in patients with breast cancer or other solid tumors, enrolling 260 participants across multiple countries. Completed trials include NCT05894928, NCT06028425, and NCT06102512, which evaluated the drug in healthy participants.
LOXO-783 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial information. It is a distinct small molecule being developed by Eli Lilly and Company for potential use in oncology.