Skip to main content
PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
Pan-Mutant Selective PI3Kα Inhibitor
LY4064809
Phase
2
Recruiting
Recruiting Info
First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumorsa
Related Resources:
PIKALO-1 Trial
Key Inclusion Criteria
  • Have an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort)
  • New or recent tumor biopsy or will provide an adequate tissue sample prior to screening
  • Tumor harbors a documented PI3Kα mutation
  • ≥18 years of age at the time of signing the Informed Consent Form (ICF)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
Key Exclusion Criteria
  • History (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied
  • Symptomatic brain or spinal metastases
  • Diagnosis of uncontrolled diabetes mellitus (defined as HbA1c ≥8% and/or fasting blood glucose [FBG] ≥140 mg/dL [7.7 mmol/L] and/or requiring or required insulin)
  • Prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances
  • Treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to the initiation of study treatment up to a maximum washout period of 28 days
    • Endocrine therapy does not require a washout period if enrolling in a cohort with the same combination endocrine therapy
  • Unresolved toxicities from previous anticancer therapies, with the exception of alopecia and peripheral neuropathy
  • Radiotherapy within 14 days before the initiation of study treatment
a
This clinical trial is being conducted globally.
b
Focus on PIK3CA mutant HR+/HER2- breast cancer.
c
Cohorts B1, C1, D1, and E1 are randomized.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
REQUEST A MEDICAL SCIENCE LIAISON

or visit www.clinicaltrials.gov for more information on this trial