RecruitingPhase 1Phase 2NCT04977453

GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib 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)


Sponsor

GI Innovation, Inc.

Enrollment

317 participants

Start Date

Aug 2, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new investigational drug called GI-101 (or GI-101A) — either alone or combined with immunotherapy or targeted therapy — in people with advanced solid tumors. GI-101 is designed to both stimulate immune cells and block tumor immune-evasion signals at the same time. **You may be eligible if...** - You are 18 or older with an advanced solid tumor - Your cancer is measurable on scans - You are in good overall health (ECOG 0–1) - Previous treatment side effects have mostly resolved - If HIV-positive, your infection is well-controlled on treatment **You may NOT be eligible if...** - Your cancer has spread to the brain or brain lining - You have an active second cancer - You have active hepatitis B, hepatitis C, or tuberculosis - You have an autoimmune disease requiring treatment in the past 2 years - You have a history of immune deficiency or are on immune-suppressing medicines Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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

View Full Details on ClinicalTrials.gov

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NCT04977453


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