GI-101 as a Single Agent or in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Advanced Solid Tumors

Non-small Cell Lung Cancer Clinical Trial

Official title:
A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 as a Single Agent and in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)

Status Recruiting

Clinical Trial 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, lenvatinib or local radiotherapy (RT) over a range of advanced and/or metastatic solid tumors.

Clinical Trial Description

This is a phase 1/2, open-label, dose-escalation and expansion study to evaluate the safety, tolerability and anti-tumor effect of GI-101/GI-101A as a single agent or in combination with pembrolizumab, lenvatinib or local RT over a range of advanced and/or metastatic solid tumors. 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) ;

Study Design

Related Conditions & MeSH terms

Advanced Solid Tumor
Carcinoma
Carcinoma, Merkel Cell
Carcinoma, Squamous Cell
Cervical Cancer
Colorectal Neoplasms
Esophageal Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
Melanoma
Merkel Cell Carcinoma
Metastatic Solid Tumor
Microsatellite Stable Colorectal Carcinoma
Neoplasms
Non-small Cell Lung Cancer
Renal Cell Carcinoma
Sarcoma
Squamous Cell Carcinoma of Head and Neck
Urinary Bladder Cancer
Urinary Bladder Neoplasms
Vaginal Cancer
Vaginal Neoplasms
Vulvar Cancer
Vulvar Neoplasms

Clinical Trial Details

NCT number	NCT04977453
Study type	Interventional
Source	GI Innovation, Inc.
Contact	Recruiting sites have contact information. Please contact the si
Phone	+82-2-404-2003
Email	clinical@gi-innovation.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	August 2, 2021
Completion date	October 2026

View Details

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