Evaluating GI-101 with Pembrolizumab, Lenvatinib, or Radiotherapy in Advanced Solid Tumors
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)
This study is testing a new treatment called GI-101, alone and with other therapies, to see if it can help people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 317 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GI Innovation, Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab, lenvatinib, chemotherapy, immunotherapy |
| Locations | 8 sites (New York, New York and 7 other locations) |
| Trial ID | NCT04977453 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A, both as a standalone treatment and in combination with pembrolizumab, lenvatinib, or local radiotherapy, for patients with advanced or metastatic solid tumors. The study is structured into six parts, including dose-escalation and expansion cohorts for both GI-101 and GI-101A, allowing for a comprehensive evaluation of these therapies. Participants will be monitored for anti-tumor effects and any adverse reactions throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with measurable advanced solid tumors and adequate organ function.
Not a fit: Patients with active CNS metastases, second malignancies, or uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors, potentially improving their outcomes.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Exclusion Criteria: * 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 exclusion criteria may apply. Cancer type and part-specific inclusion criteria are described in the study protocol.
Where this trial is running
New York, New York and 7 other locations
- Tisch Cancer Institute (TCI), Icahn School of Medicine — New York, New York, United States (Recruiting)
- Carolina Biooncology Institute — Huntersville, North Carolina, United States (Recruiting)
- Chungnam National University Hospital — Daejeon, Daejeon, South Korea (Recruiting)
- The Catholic University of Korea St. Vincent's Hospital — Suwon, Kyeonggi-do, South Korea (Recruiting)
- Korea University Anam Hospital — Seoul, Seongbuk-gu, South Korea (Recruiting)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Recruiting sites have contact information. Please contact the sites directly.
- Email: clinical@gi-innovation.com
- Phone: +8224042003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.