About this trial
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
Eligibility criteria
Qualifiers
Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
Aged at least 18 years as of the date of consent.
Unresectable Stage III or Stage IV melanoma patients, who have had disease progression on or after at least one prior ICI containing treatment. Patients with mucosal and uveal melanoma types are to be excluded.
There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disqualifiers
Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.
Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor.
Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days).
Prior therapy with any chemotherapy, immunotherapy, anticancer agents or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body.
Trial design
Treatments tested in this trial
- ATG-037
- KEYTRUDA ®( Pembrolizumab)
Treatment groups
Sponsors and collaborators
Antengene Therapeutics Limited
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator