A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Loxo Oncology, Inc.
• Treatments: Anastrozole; Exemestane; Fulvestrant; Letrozole; Paclitaxel

Criteria

Inclusion Criteria:

• Have advanced breast cancer or another solid tumor with the presence of a PIK3CA H1047R mutation (or other Sponsor and SRC-approved, activating PIK3CA mutations other than H1047R mutation)

• Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.

• Have stopped all cancer treatment and have recovered from the major side effects

• Have adequate organ function, as measured by blood tests

• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

• Patients must have

• Measurable disease

--- Patients with non-breast tumor types must have at least 1 measurable lesion

• Non-measurable bone-only disease (breast cancer patients only)

• For patients with an ER+ breast cancer diagnosis:

• If female, must be postmenopausal

• If male, must agree to use hormone suppression

• Phase 1a:

-- Dose escalation and backfill patients:

• Advanced solid tumor

• Patients may have had up to 5 prior regimens

• Phase 1b:

• Part A:

• ER+/HER2- advanced breast cancer

• Patients may have had up to 2 prior regimens for advanced disease

• Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required

• Part B:

• ER+/HER2- advanced breast cancer

• Patients may have had up to 2 prior regimens for advanced disease.

• Part C:

• ER+/HER2- advanced breast cancer

• Patients may have had up to 5 prior regimens for advanced disease.

---- Prior CDK4/6 inhibitor therapy required.

• Have a diagnosis of diabetes mellitus Type 2

• Part D:

• Advanced breast cancer

• Patients may have had up to 5 prior regimens for advanced disease.

• Part E:

• Advanced solid tumor

• Patients may have had up to 3 prior regimens for advanced disease

Exclusion Criteria:

• Medical Conditions

• Colorectal cancer

• Endometrial cancers with specific concurrent oncogenic alterations

• A history of known active or suspected

• Diabetes mellitus Type 1 or

• Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).

• Serious concomitant systemic disorder

• Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.

• Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process

• Prior exposure to PI3K/AKT/mTOR inhibitor(s), except in certain circumstances