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

Status
Active
Cancer Type
Breast Cancer
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05307705
Protocol IDs
LOXO-PIK-21001 (primary)
NCI-2022-04290
2022-000175-40
J4C-OX-JZUA
Study Sponsor
Eli Lilly and Company

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

  1. 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)
  2. Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
  3. Have stopped all cancer treatment and have recovered from the major side effects
  4. Have adequate organ function, as measured by blood tests
  5. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  6. Patients must have
  7. Measurable disease --- Patients with non-breast tumor types must have at least 1 measurable lesion
  8. Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)
  9. For patients with an estrogen receptor (ER)+ breast cancer diagnosis:
  10. If female, must be postmenopausal
  11. If male, must agree to use hormone suppression
  12. Phase 1a: -- Dose escalation and backfill patients:
  13. Advanced solid tumor
  14. Patients may have had up to 5 prior regimens for advanced disease
  15. Phase 1b:
  16. Part A:
  17. ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer
  18. Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
  19. Part B:
  20. ER+/HER2- advanced breast cancer
  21. Patients may have had up to 2 prior regimens for advanced disease.
  22. Part C:
  23. ER+/HER2- advanced breast cancer
  24. Patients may have had up to 5 prior regimens for advanced disease. ---- Prior CDK4/6 inhibitor therapy required.
  25. Have a diagnosis of diabetes mellitus Type 2
  26. Part D:
  27. Advanced breast cancer
  28. Patients may have had up to 5 prior regimens for advanced disease.
  29. Part E:
  30. Advanced solid tumor
  31. Patients may have had up to 3 prior regimens for advanced disease advanced disease
  32. Part F:
  33. ER+/HER2- advanced breast cancer
  34. Patients may have had up to 5 prior regimens for advanced disease
  35. Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.