Actively Recruiting
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
Led by GI Innovation, Inc. · Updated on 2026-03-17
317
Participants Needed
8
Research Sites
360 weeks
Total Duration
On this page
Sponsors
G
GI Innovation, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older (or 19 years or older per local guidelines) at screening
- Adequate organ and marrow function as defined in the protocol
- Measurable disease according to RECIST version 1.1
- ECOG performance status of 0 or 1
- Side effects from prior chemotherapy, radiotherapy, immunotherapy, other systemic anti-cancer therapy, or surgery must have resolved to Grade 1 or less, except alopecia and Grade 2 peripheral neuropathy
- HIV-infected patients must be on anti-retroviral therapy with well-controlled infection
You will not qualify if you...
- Known active central nervous system metastases or carcinomatous meningitis
- Active second malignancy
- Active or history of hepatitis B or active hepatitis C infection
- Active or history of active tuberculosis
- Active infections, uncontrolled infections, or severe infection within 4 weeks before treatment
- History of chronic liver disease or liver cirrhosis except with liver metastasis
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Previous immunotherapies targeting GI-101's mode of action
- Diagnosis of immunodeficiency or current chronic systemic steroid or immunosuppressive therapy within 2 weeks before cycle 1 day 1
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks before treatment
- Radiotherapy within 2 weeks before treatment except limited field palliative radiotherapy
- Live, attenuated vaccine administration within 4 weeks before cycle 1 day 1
- Known allergy to components of GI-101, GI-101A, pembrolizumab, or lenvatinib
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Tisch Cancer Institute (TCI), Icahn School of Medicine
New York, New York, United States, 10029-5674
Actively Recruiting
2
Carolina Biooncology Institute
Huntersville, North Carolina, United States, 28078
Actively Recruiting
3
Chungnam National University Hospital
Daejeon, Daejeon, South Korea, 65015
Actively Recruiting
4
The Catholic University of Korea St. Vincent's Hospital
Suwon, Kyeonggi-do, South Korea, 16247
Actively Recruiting
5
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea, 02841
Actively Recruiting
6
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
7
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
8
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
R
Recruiting sites have contact information. Please contact the sites directly.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here