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Brief Title: Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors and Hematological Malignancies
Official Title: A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Patients With Advanced Solid Tumors and Hematological Malignancies
Study ID: NCT04305249
Brief Summary: This is a Phase I, multi-center, open-label study of ATG-017 administered orally, alone or in combination with nivolumab in patients with advanced solid tumors and hematological malignancies. The study is composed of two modules: ATG-017 monotherapy (Module A) and ATG-017 in combination with nivolumab (Module B). Both Modules A and B will include Dose Escalation Phase and Dose Expansion Phase.
Detailed Description: The dose escalation of ATG 017 will be conducted with intensive safety monitoring to ensure the safety of the patients with solid tumors (Module A and Module B) and hematological malignancies (Module A) harbouring activating alterations in the RAS-MAPK pathway, and will include the continuous and intermittent dosing schedules. The Dose Expansion Phase will start based on dose level and schedule (continuous or intermittent)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Scientia Clinical Research, Randwick, , Australia
Chris O'Brien Lifehouse, Sydney, , Australia
Name: Sai Lou, MD
Affiliation: Clinical Research Physician
Role: STUDY_DIRECTOR
Name: Anupa Kudva, MD
Affiliation: Clinical Research Physician
Role: STUDY_DIRECTOR
Name: Yiqiang Zhao, MD
Affiliation: Executive Director
Role: STUDY_DIRECTOR