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)
GI Innovation, Inc.
Summary
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.
Description
This is 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 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 E: Dose-esca…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 infect…
Interventions
- DrugGI-101
Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
- DrugPembrolizumab (KEYTRUDA®)
Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
- DrugLenvatinib
Lenvatinib will be administered at an approved dose orally.
- DrugGI-101A
Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Locations (8)
- Tisch Cancer Institute (TCI), Icahn School of MedicineNew York, New York
- Carolina Biooncology InstituteHuntersville, North Carolina
- Chungnam National University HospitalDaejeon, Daejeon
- The Catholic University of Korea St. Vincent's HospitalSuwon, Kyeonggi-do
- Korea University Anam HospitalSeoul, Seongbuk-gu
- Yonsei University Health System, Severance HospitalSeoul