Tests GI-102 alone and with other drugs in advanced solid tumors
Tests GI-102, alone or with other cancer drugs, in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Seoul and Suwon, South KoreaSee the 5 sites
- Phase
- Phase 1/2
Where in South Korea
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Yonsei University Health System, Severance HospitalSeoul, South KoreaTaking people
- St. Vincent's HospitalSuwon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GI Innovation, Inc.
- Trial code
- NCT05824975
- Record updated
- 25 November 2024
- Original description
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.Read full original descriptionShow less
An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)
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.
Inclusion: 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: Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration; 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; 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; 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; 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; Has known active CNS metastases and/or carcinomatous meningitis.