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

A Phase 1/2 Study to Evaluate Safety, Tolerability, PK, and Therapeutic Activity of GI-101 as a Single Agent and in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients With Advanced, Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: GII-101-P101 (MK-3475-B59)
  • Secondary ID: KEYNOTE-B59
  • NTC ID: NCT04977453
  • Sponsor: GI Innovation, Inc.

BRIEF SUMMARY

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101 as a single agent or in combination with pembrolizumab, lenvatinib or local radiotherapy (RT) over a range of advanced and/or metastatic solid tumors.

DETAILED 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 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 four 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

GI-101 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.

Drug Information available for: Pembrolizumab (https://www.keytrudahcp.com), Lenvatinib (http://www.lenvima.com)

  • Overall Status
    Recruiting
  • Start Date
    July 23, 2021
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence and nature of Dose-Limiting Toxicity (DLTs)

Primary Outcome 1 - Timeframe: Study Day 1, assessed up to approximately 24 months

Primary Outcome 2 - Measure: Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs)

Primary Outcome 2 - Timeframe: Study Day 1, assessed up to approximately 24 months

Primary Outcome 3 - Measure: Objective Response Rate (ORR) according to RECIST version 1.1

Primary Outcome 3 - Timeframe: Study Day 1, assessed up to approximately 24 months

CONDITION

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Non-small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Renal Cell Carcinoma
  • Urinary Bladder Cancer
  • Melanoma
  • Sarcoma

ELIGIBILITY

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 infection/disease as defined in protocol.
Key Exclusion Criteria:
Has known active CNS metastases and/or carcinomatous meningitis.

- An active second malignancy

- Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.

- Has active tuberculosis or has a known history of active tuberculosis

- Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.

- History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.

- Has an active autoimmune disease that has required systemic treatment in past 2 years.

- Previous immunotherapies related to mode of action of GI-101.

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.

- Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.

- Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy (except Part D).

- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.

- Known hypersensitivity to any of the components of the drug products and/or excipients of GI-101, pembrolizumab or lenvatinib.
Other protocol defined inclusion exclusion criteria may apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nari Yun, PhD

Role: Study Director

Affiliation: GI Innovation

Overall Contact

Name: Nari Yun, PhD

Phone: +82-2-404-2003

Email: clinical@gi-innovation.com

LOCATION

Facility Status Contact
Facility: Carolina Biooncology Institute
Huntersville, North Carolina 28078
United States
Status: Recruiting Contact: Principal Investigator
John Powderly, M.D., Ph.D.

Facility: The Catholic University of Korea St. Vincent's Hospital
Suwon-si, Kyeonggi-do 16247
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Byoung-Yong Shim, M.D., Ph.D.

Facility: Chungnam National University Hospital
Daejeon, 65015
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
HyoJin Lee, M.D., Ph.D.

Facility: Yonsei University Health System, Severance Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Byoung Chul Cho, M.D., Ph.D.

Facility: Yonsei University Health System, Severance Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: Sub-Investigator
Sang Joon Shin, M.D., Ph.D.

Facility: Asan Medical Center
Seoul, 05505
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Jung-Yun Lee, M.D., Ph.D.