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)
Sponsored by GI Innovation, Inc.
About this study
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.
This is a phase 1/2, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, and anti-tumor effect 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. This study is adaptive in nature. The study is composed of four parts: * Part A: Dose escalation and optimization phase of GI-102 intravenous (IV) monotherapy * Part A dose escalation phase * Part A dose optimization phase: Dose optimization cohorts in patients with 2L+, CPI-refractory metastatic melanoma * Part B: Dose escalation and expansion phase of GI-102 subcutaneous (SC) monotherapy * Part C: Indication specific cohorts of GI-102 IV in combination with conventional…
Where this study is enrolling
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Mayo Clinic in Arizona
Scottsdale, Arizona
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Who can participate
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.
Exclusion criteria
- ✕Has known active CNS metastases and/or carcinomatous meningitis.
- ✕An active second malignancy.
- ✕Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.
- ✕Has active tuberculosis or has a known history of active tuberculosis.
- ✕Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.
- ✕History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.
- ✕Has an active autoimmune disease that has required systemic treatment in past 2 years.
- ✕Previous immunotherapies related to mode of action of GI-102.
- ✕Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.
- ✕Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
- ✕Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy.
- ✕Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
- ✕Known hypersensitivity to any of the components of the drug products and/or excipients of GI-102.
- ✕Other protocol defined inclusion exclusion criteria may apply
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Trial data sourced from ClinicalTrials.gov.