A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
Eligibility Criteria
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 as of the date of consent. 3. 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. 4. There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Estimated life expectancy of a minimum of 12 weeks. 6. Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD\>6 months). 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature. 8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding. 9. Male subjects should be willing to use barrier contraception, ie condoms, for the dur