癌研連線CancerLink
Recruiting NCT05307705

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

Breast CancerColorectal CancerCervical / Gynecologic CancerPhase 1Stage IIIStage IVEGFRHER2PIK3CA

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.

Conditions: Breast Cancer

Eligibility Criteria

Inclusion Criteria

  • 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)
  • 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 disease (at least 1 bone lesion in breast cancer patients only)
  • For patients with an estrogen receptor (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 for advanced disease
  • Phase 1b:
  • Part A:
  • ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer
  • Patients may have had up to 5 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

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 phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.