drugset / Trial / NCT05824975
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.
Timeline
- Start
- 2023-05-30
- Primary completion
- 2025-11-12
- Completion
- 2027-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | GI-102 | Protein / enzyme biologic | 0.06 mg/kg | Intravenous |
| Subject | GI-102 | Protein / enzyme biologic | 0.12 mg/kg | Intravenous |
| Subject | GI-102 | Protein / enzyme biologic | 0.24 mg/kg | Intravenous |
| Subject | GI-102 | Protein / enzyme biologic | 0.45 mg/kg | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 6.4 mg/kg | Intravenous |