GI-101 as a Single Agent or in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Advanced Solid Tumors
NCT ID: NCT04977453
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
430 participants
INTERVENTIONAL
2021-08-02
2026-12-31
Brief Summary
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Detailed Description
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This study will comprise six parts.
* Part A: Dose-escalation and expansion cohorts of GI-101 monotherapy
* Part B: Dose-escalation and expansion cohorts of GI-101 plus pembrolizumab
* Part C: Dose-optimization and expansion cohorts of GI-101 plus lenvatinib
* Part D: Dose-optimization and expansion cohorts of GI-101 plus local RT
* Part E: Dose-escalation and expansion cohorts of GI-101A monotherapy
* Part F: Dose-escalation and expansion cohorts of GI-101A plus pembrolizumab
GI-101/GI-101A is a novel bi-specific Fc fusion protein containing the CD80 ectodomain as an N-terminal moiety and an interleukin (IL)-2 variant as a C-terminal moiety configurated via a human immunoglobulin G4 (IgG4) Fc.
GI-101A is an abbreviation of advanced GI-101 with an improved formulation for manufacture consistency.
Drug Information available for: Pembrolizumab (https://www.keytrudahcp.com), Lenvatinib (http://www.lenvima.com)
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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GI-101
Dose escalation: GI-101, multiple ascending doses
Dose expansion:
GI-101
Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
GI-101 + Pembrolizumab
Dose escalation: GI-101, multiple ascending doses
Dose expansion:
GI-101
Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Pembrolizumab (KEYTRUDA®)
Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
GI-101 + Lenvatinib
Dose optimization:
Dose expansion:
GI-101
Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Lenvatinib
Lenvatinib will be administered at an approved dose orally.
GI-101 + Local Radiotherapy
Dose optimization:
Dose expansion:
GI-101
Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Local Radiotherapy
Patients will receive SBRT prior to the first dose of GI-101
GI-101A
Dose escalation: GI-101A, multiple ascending doses
Dose expansion:
GI-101A
Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
GI-101A + Pembrolizumab
Dose escalation: GI-101A, multiple ascending doses
Dose expansion:
Pembrolizumab (KEYTRUDA®)
Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
GI-101A
Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Interventions
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GI-101
Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Pembrolizumab (KEYTRUDA®)
Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
Lenvatinib
Lenvatinib will be administered at an approved dose orally.
Local Radiotherapy
Patients will receive SBRT prior to the first dose of GI-101
GI-101A
Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 (except Part D).
* 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, pembrolizumab or lenvatinib.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
GI Innovation, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nari Yun, PhD
Role: STUDY_DIRECTOR
GI Innovation
Locations
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Tisch Cancer Institute (TCI), Icahn School of Medicine
New York, New York, United States
Carolina Biooncology Institute
Huntersville, North Carolina, United States
Chungnam National University Hospital
Daejeon, Daejeon, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, Kyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Recruiting sites have contact information. Please contact the sites directly.
Role: CONTACT
Other Identifiers
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KEYNOTE-B59
Identifier Type: OTHER
Identifier Source: secondary_id
GII-101-P101 (MK-3475-B59)
Identifier Type: -
Identifier Source: org_study_id
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