Tests GI-101 alone or with other drugs in advanced solid tumors
Tests GI-101 alone or with pembrolizumab or lenvatinib in adults with advanced cancers.
Plain-language title generated from the registry record
Registry title: GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
Key facts
- Where
- Daejeon, Seoul, and Suwon, South KoreaSee the 9 sites
- Phase
- Phase 1/2
Where in South Korea
- Chungnam National University HospitalDaejeon, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Ewha Womans University Mokdong HospitalSeoul, South KoreaTaking people
- Korea University Anam HospitalSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University Bundang HospitalSeoul, South KoreaTaking people
- The Catholic University of Korea, Seoul ST. Mary's HospitalSeoul, South KoreaTaking people
- Yonsei University Health System, Severance HospitalSeoul, South KoreaTaking people
- The Catholic University of Korea 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
- NCT04977453
- Record updated
- 19 October 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.Read full original descriptionShow less
A Phase 1/2, Open-label, Dose-escalation, Dose-optimization and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101/GI-101A as a Single Agent and in Combination With Pembrolizumab or Lenvatinib in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib 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-101; 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-101/GI-101A, pembrolizumab or lenvatinib; Other protocol defined inclusion exclusion criteria may apply. Cancer type and part-specific inclusion criteria are described in the study protocol; Has known active CNS metastases and/or carcinomatous meningitis.