Brief Summary
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advancedat a late stage, far along or Metastatic Solid Tumors.
Intervention / Treatment
- Drug: ATG-037
- Drug: KEYTRUDA ®( Pembrolizumab)
Inclusion Criteria
- Provision of signed and dated, written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. prior to any study-specific procedures, sampling, and analyses.
- Aged at least 18 years as of the date of consent.
- Histological or cytological confirmation of a solid tumor that has relapsed from or refractory to standard therapies.
- There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Estimated life expectancy of a minimum of 12 weeks.
- Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD>6 months).
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status 0 or 1 at ICF signature.
- Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding.
- Male subjects should be willing to use barrier contraception, ie condoms, for the duration of the study and 180 days after the final dosethe amount of medication taken of study treatment.
- Subjects should have adequate organ function.