A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
LOXO-783: Oral
Fulvestrant: Intramuscular
Imlunestrant: Oral
Abemaciclib: Oral
Anastrozole, Exemestane, or Letrozole: Oral
Paclitaxel: Intravenous
Study summary
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Eligibility
Primary outcome measure(s)
- Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs) — During the first 28-day cycle of LOXO-783 treatment
Number of patients with DLTs - Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities — During the first 28-day cycle of LOXO-783 treatment
Number of patients with DLT-equivalent toxicities
Trial sites (50)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic of Scottsdale | Scottsdale | Arizona | Not Yet Recruiting |
| UCLA Medical Center | Los Angeles | California | Completed |
| UCSF Medical Center at Mission Bay | San Francisco | California | Recruiting |
| Stanford University Hospital | Stanford | California | Recruiting |
| Mayo Clinic | Jacksonville | Florida | Not Yet Recruiting |
| Winship Cancer Center Emory University | Atlanta | Georgia | Completed |
| Massachusetts General Hospital | Boston | Massachusetts | Completed |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Not Yet Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Washington University Medical School | St Louis | Missouri | Not Yet Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Completed |
| Wilmot Cancer Institute | Rochester | New York | Not Yet Recruiting |
| Tennessee Oncology PLLC | Nashville | Tennessee | Completed |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | Not Yet Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | Not Yet Recruiting |
| South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas | Not Yet Recruiting |
| Cancer Research SA | Adelaide | Australia | Not Yet Recruiting |
| Peter Maccallum Cancer Institute Erb | East Melbourne | Australia | Not Yet Recruiting |
| St Vincent's Hospital | Sydney | Australia | Not Yet Recruiting |
| Institut Jules Bordet | Anderlecht | Belgium | Not Yet Recruiting |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | Not Yet Recruiting |
| Princess Margaret Hospital (Hong Kong) | Toronto | Canada | Not Yet Recruiting |
| BC Cancer Vancouver | Vancouver | Canada | Recruiting |
| Beijing Cancer hospital | Beijing | China | Not Yet Recruiting |
| The Third Hospital of Nanchang | Nanchang | China | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | China | Not Yet Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
| Institut Curie | Paris | France | Not Yet Recruiting |
| Institut de Cancérologie de l'Ouest | Saint-Herblain | France | Recruiting |
| ICANS_Institut de Cancerologie Strasbourg Europe | Strasbourg | France | Recruiting |
| Gustave Roussy | Villejuif | France | Not Yet Recruiting |
| Universitätsklinikum Erlangen | Erlangen | Germany | Not Yet Recruiting |
| National Cancer Center Hospital | Chūōku | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR | Kōtō City | Japan | Recruiting |
| Kyoto University Hospital | Kyoto | Japan | Not Yet Recruiting |
| Aichi Cancer Center Hospital | Nagoya | Japan | Recruiting |
| National Cancer Centre Singapore | Singapore | Singapore | Not Yet Recruiting |
| Samsung Medical Center | Seoul | South Korea | Not Yet Recruiting |
| Asan Medical Center | Seoul | South Korea | Not Yet Recruiting |
+ 10 more sites — see the full list on the official registry below.
On this site
📄 Verzenio (abemaciclib) drug profile →More Eli Lilly and Company trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05307705 on ClinicalTrials.gov ↗ ← All trials in South Korea