Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors and Hematological Malignancies

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 -