A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
| Condition(s) | Locally Advanced or Metastatic Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors |
| Who can participate | 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 b |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Antengene Therapeutics Limited |
| Locations | Sydney, New South Wales, Australia; Benowa, Queensland, Australia; Bedford Park, South Australia, Australia; Frankston, Victoria, Australia; Mount Pleasant, Western Australia, Australia; Chongqing, Chongqing Municipality, China (+1 more sites) |
| Start date | 2022-06-07 |
| NCT ID | NCT05205109 |
| Official listing | https://clinicaltrials.gov/study/NCT05205109 |