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

ATG-017-001

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.

2020-08-15

2024-02-29

2024-06-30

Recruiting

Early phase I

211

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. 2. Aged at least 18 years. 3. Module A: Patient must have a documented activating alteration of the RAS-MAPK pathway. 4. 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. 5. Histological or cytological confirmation of a solid tumour. 6. Patient with solid tumors must have at least 1 lesion, not previously irradiated. 7. Estimated life expectancy of minimum of 12 weeks. 8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 9. Ability to swallow and retain oral medication. Exclusion Criteria: 1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression. 2. Prior ATG-017 administration in the present study. 3. Prior treatment with an ERK1/2 inhibitor. 4. Prior major surgery within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days. 5. Patients receiving unstable or increasing doses of corticosteroids. 6. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases. 7. Active infection including hepatitis B, and/or hepatitis C. 8. Known history of human immunodeficiency virus (HIV) infection. 9. Inadequate bone marrow reserve or organ function -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 211, 'type': 'ESTIMATED'}}

2024-04-16