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Oncology Clinical Trial Finder
Breast Cancer
Location

Terminated • Phase I • Stage III, IV • ER negative • PR negative • HER2 negative • Medical Oncology • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

This is an open-label, multicenter, First-In-Human (FIH), Phase 1a/1b study of PY159 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to Standard Of Care (including Checkpoint Inhibitors, if approved for that indication).

Part A: Dose escalation of PY159 alone and in combination with pembrolizumab in a standard 3+3 design Part B: Dose expansion of one or more dose levels of PY159 administered alone and in combination with pembrolizumab for predefined tumor histology

Breast Cancer

Study Design
Study type:

Interventional

Estimated enrollment:

127 participant

Actual study start date:

November 10, 2020

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:

both


Arms and Intervention
  • PY159 Single agent dose level 1

  • PY159 Single agent dose level 2

  • PY159 Single agent dose level 3

  • PY159 Single agent dose level 4

  • PY159 Single agent dose level 5

  • PY159 Single agent dose level 6

  • PY159 Single agent dose level 7

  • PY159/Pembrolizumab Combination dose level 1

  • PY159/Pembrolizumab Combination dose level 2

  • PY159/Pembrolizumab Combination dose level 3

  • PY159/Pembrolizumab Combination dose level 4

  • PY159 Single agent dose expansion cohort

  • PY159/Pembrolizumab Combination dose expansion cohort 1

  • PY159/Pembrolizumab Combination dose expansion cohort 2

  • PY159/Pembrolizumab Combination dose expansion cohort 3

  • PY159/Pembrolizumab Combination dose expansion cohort 4

  • PY159/Pembrolizumab Combination dose expansion cohort 5

  • PY159/Pembrolizumab Combination dose expansion cohort 6

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:

Terminated

Estimated Enrollment:

127

Last Updated:

03/24/2024


Principal Investigator

Len Reyno, MD


Trial Sponsor

Ikena Oncology

Study Location (17)

Case Western Reserve University

Cleveland, Ohio, United States

Florida Cancer Specialists - Sarasota - SCRI

Sarasota, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mary Crowley Cancer Center

Dallas, Texas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

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