Clinical Trial: NCT05307705
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Eli Lilly and Company |
| Information Provided By: | Eli Lilly and Company |
| Last Update Posted: | 2026-10-14 |
Study Overview
Brief 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.
Official Title
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
Conditions
Breast Cancer
Intervention / Treatment
- Drug: LOXO-783
- Drug: Fulvestrant
- Drug: Imlunestrant
- Drug: Abemaciclib
- Drug: Anastrozole, Exemestane, or Letrozole
- Drug: Paclitaxel
Other Study ID Numbers
- 18394
- 2022-000175-40
- J4C-OX-JZUA
- LOXO-PIK-21001
Start Date (Actual)
2022-05-11
Primary Completion Date (Actual)
2025-04-02
Study Completion Date (Estimated)
2026-12
Enrollment (Estimated)
260
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Eli Lilly and Company |
| Information Provided By: | Eli Lilly and Company |
| Last Update Posted: | 2026-10-14 |
Study Overview
Brief 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.
Official Title
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
Conditions
Breast Cancer
Intervention / Treatment
- Drug: LOXO-783
- Drug: Fulvestrant
- Drug: Imlunestrant
- Drug: Abemaciclib
- Drug: Anastrozole, Exemestane, or Letrozole
- Drug: Paclitaxel
Other Study ID Numbers
- 18394
- 2022-000175-40
- J4C-OX-JZUA
- LOXO-PIK-21001
Start Date (Actual)
2022-05-11
Primary Completion Date (Actual)
2025-04-02
Study Completion Date (Estimated)
2026-12
Enrollment (Estimated)
260
Study Type
Interventional
Phase
Phase 1