NCT04977453 - GI-101 as a Single Agent or in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Advanced Solid Tumors | Biotech Hunter

Enrollment

430

Participants

Timeline

Start Date

August 2, 2021

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2026

Conditions

Advanced Solid TumorMetastatic Solid TumorNon-small Cell Lung CancerHead and Neck Squamous Cell CarcinomaRenal Cell CarcinomaUrinary Bladder CancerMelanomaSarcomaMicrosatellite Stable Colorectal CarcinomaMerkel Cell CarcinomaEsophageal Squamous Cell CarcinomaCervical CancerVaginal CancerVulvar Cancer

Interventions

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.

RADIATION

Local Radiotherapy

Patients will receive SBRT prior to the first dose of GI-101

DRUG

GI-101A

Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).

Trial Locations (8)

16247

RECRUITING

The Catholic University of Korea St. Vincent's Hospital, Suwon

28078

RECRUITING

Carolina Biooncology Institute, Huntersville

65015

RECRUITING

Chungnam National University Hospital, Daejeon

10029-5674

RECRUITING

Tisch Cancer Institute (TCI), Icahn School of Medicine, New York

02841

RECRUITING

Korea University Anam Hospital, Seoul

03722

RECRUITING

Yonsei University Health System, Severance Hospital, Seoul

RECRUITING

Yonsei University Health System, Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul