Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors and Hematological Malignancies (ERASER)
Solid Tumor, Hematological Malignancy
About this trial
This is an interventional treatment trial for Solid Tumor
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
- Aged at least 18 years.
- Module A: Patient must have a documented activating alteration of the RAS-MAPK pathway.
- Module B: Dose Escalation Phase: Patient must have a documented activating alteration of the RAS-MAPK pathway; Dose Expansion Phase: Expansion cohorts will be further defined based on information from the Dose Escalation.
- Histological or cytological confirmation of a solid tumour.
- Patient with solid tumors must have at least 1 lesion, not previously irradiated.
- Estimated life expectancy of minimum of 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Ability to swallow and retain oral medication.
Exclusion Criteria:
- Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression.
- Prior ATG-017 administration in the present study.
- Prior treatment with an ERK1/2 inhibitor.
- Prior major surgery within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
- Patients receiving unstable or increasing doses of corticosteroids.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
- Active infection including hepatitis B, and/or hepatitis C.
- Known history of human immunodeficiency virus (HIV) infection.
Inadequate bone marrow reserve or organ function
-
Sites / Locations
- Peter MacCallum Cancer CentreRecruiting
- Austin HospitalRecruiting
- Alfred HospitalRecruiting
- Scientia Clinical ResearchRecruiting
- Chris O'Brien LifehouseRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Module A (ATG-017 Monotherapy)
Module B (ATG-017+Nivolumab Combination Therapy in Solid Tumors)
Dosing will begin at 5 mg QD ATG-017 as starting dose. A treatment cycle will be 21 days for continuous dosing and 28 days for 7 days on/7 days off intermittent dosing of ATG-017 treatment.
With the combination with nivolumab, a cycle of study treatment will be defined as 28 days. ATG-017 is planned initially to be continuously given 28 days in each cycle. ATG-017 dosing schedule in combination therapy will follow a similar dose escalation principle as with monotherapy but starting at 5 mg BID. Nivolumab will be given at fixed dosing, 480 mg Q4W, on D1 of each cycle.