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Terminated • Phasen I • Stufe III, IV • ER negativ • PR negativ • HER2 negativ • Medical Oncology • Post-Menopausal • Interventionell

Folgendes wird aus ClinicalTrials.gov importiert:

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

Studiendesign
Studientyp:

Interventional

Geschätzte Einschreibung:

127 Teilnehmer

Aktueller Studienbeginn:

10. November 2020

Zulassungskriterien
Alter für die Studie berechtigt:

18 - 999

Geschlechter für die Studie berechtigt:

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:
Studieninformationen
ClinicalTrial.gov ID:

Terminated

Estimated Enrollment:

127

Last Updated:

03/24/2024


Hauptermittler

Len Reyno, MD


Studiensponsor

Ikena Oncology

Study Location (17)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Case Western Reserve University

Cleveland, Ohio, United States

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