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Spots Global Cancer Trial Database for Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors and Hematological Malignancies

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Trial Identification

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

Study Description

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)

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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