NCT04977453

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 317 (estimated)
• Sponsor: GI Innovation, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-escalation cohorts of GI-101A monotherapy * Part F: Dose-escalation cohorts of GI-101A plus pembrolizumab * Part G: Dose-optimization and indication-specific cohorts of GI-101A plus pembrolizumab * Part G1: Dose optimization cohorts in CPI-refractory urothelial cancer * Part G2: Indication-specific cohorts in CPI-refractory ccRCC, squamous cell NSCLC and SoC-experienced MSS/pMMR CRC 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)

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Cervical Cancer
• Urothelial Carcinoma
• Clear Cell Renal Cell Cancer (ccRCC)
• Squamous Cell Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GI-101	Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
DRUG	Pembrolizumab (KEYTRUDA®)	Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
DRUG	Lenvatinib	Lenvatinib will be administered at an approved dose orally.
DRUG	GI-101A	Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).

Timeline

• Start date: 2021-08-02
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2021-07-27
• Last updated: 2026-03-17

Locations

8 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study