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RecruitingLast updated: 2 February 2024

PIKASSO-01: This phase I study is evaluating how safe and effective targeted therapy (LOXO-783) is alone, or when given with other anti-cancer therapies (such as fulvestrant, imlunestrant, abemaciclib, paclitaxel, and aromatase inhibitors) in people with advanced breast cancer or other solid cancers with a PIK3CA H1047R mutationA 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

Clinical summary

Summary

This trial has two phases. In phase 1A, eligible participants will receive LOXO-783 as monotherapy, administered orally, in escalating doses. The next phase, Phase 1B, has six arms. In Phase 1B Part A, participants will receive LOXO-783 (administered orally) in combination with fulvestrant (administered intramuscularly), imlunestrant (administered orally) or and aromatase inhibitor such as anastrozole, exemestane or letrozole (also administered orally). In Phase 1B Part B, participants will receive LOXO-783 (orally) in combination with abemaciclib (orally) and either physician's choice aromatase inhibitor (orally), fulvestrant (intramuscularly) or imlunestrant (orally). In Phase 1B Part C, participants will receive LOXO-783 (orally) in combination with fulvestrant (intramuscularly). In Phase 1B Part D, participants will receive LOXO-783 (orally) in combination with paclitaxel (intravenously). In Phase 1B Part E, participants will receive LOXO-783 (orally) as monotherapy. Phase 1B Part F, will involve multiple randomised dose levels of LOXO-783 (orally) with fulvestrant (intramuscularly).

Conditions

This trial is treating patients with advanced breast cancer or other solid cancers with PIK3CA H1047R mutations

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

PIKASSO-01

More information

Trial Identifiers

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Trial sponsor

Eli Lilly and Company

Scientific 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

Eligibility

Inclusion

  • 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
      • 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 advanced disease
    • Part F:

      • ER+/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

Exclusion

  • 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

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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