GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 19, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- GI Innovation, Inc.
- Interventions being studied
- Drug: GI-101; Drug: Pembrolizumab (KEYTRUDA®); Drug: Lenvatinib; Drug: GI-101A
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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-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.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Tisch Cancer Institute (TCI), Icahn School of MedicineNew York, New York
- Columbia UniversityNew York, New York
- Carolina Biooncology InstituteHuntersville, North Carolina
- The Catholic University of Korea Seoul ST.MARY'S HospitalSeoul, Banpo-daero
- Seoul National University Bundang HospitalSeoul, Bundang-gu
- Chungnam National University HospitalDaejeon, Daejeon
- Samsung Medical CenterSeoul, Gangnam
- The Catholic University of Korea St. Vincent's HospitalSuwon, Kyeonggi-do
- Korea University Anam HospitalSeoul, Seongbuk-gu
- Ewha Womans University Mokdong HospitalSeoul, Yangcheon-gu
- Yonsei University Health System, Severance HospitalSeoul
- Yonsei University Health System, Severance HospitalSeoul
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 19, 2026. Always confirm current availability with the study team.