A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in
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.
| Condition(s) | Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC), Hepatocellular Carcinoma (HCC), Colorectal Cancer (CRC), HER2 Negative Breast Cancer, |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Key Inclusion Criteria: * Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening. * Has adequate organ and marrow function as defined in protocol. * Measurable disease as per RECIST v1.1. * ECOG performance status 0-1. * Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy. * HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol. Key Exclusion Criteria: * Has known active CNS metastases and/or carcinomatous meningitis. * An active second malignancy. * Has active or a known history of Hepatiti |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | GI Innovation, Inc. |
| Locations | Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; New York, New York, United States; Cleveland, Ohio, United States; Seoul, Seoul, South Korea (+5 more sites) |
| Start date | 2023-05-30 |
| NCT ID | NCT05824975 |
| Official listing | https://clinicaltrials.gov/study/NCT05824975 |