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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, 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)

INTRODUCTION

  • Org Study ID: GII-101-P101 (MK-3475-B59)
  • Secondary ID: N/A
  • NCT 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/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.

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/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)

  • Overall Status
    Recruiting
  • Start Date
    August 2, 2021
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Study Day 1

Primary Outcome 2 - Measure: Incidence

Primary Outcome 2 - Timeframe: assessed up to approximately 24 months

Primary Outcome 3 - Measure: nature

Primary Outcome 3 - Timeframe: Study Day 1

Primary Outcome 4 - Measure: and severity of adverse events (AEs) and immune-related AEs (irAEs)

Primary Outcome 4 - Timeframe: assessed up to approximately 24 months

Primary Outcome 5 - Measure: Objective Response Rate (ORR) according to RECIST version 1.1

Primary Outcome 5 - Timeframe: Study Day 1

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
  • Microsatellite Stable Colorectal Carcinoma
  • Merkel Cell Carcinoma
  • Esophageal Squamous Cell Carcinoma
  • Cervical Cancer
  • Vaginal Cancer
  • Vulvar Cancer

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: Recruiting sites have contact information. Please contact the sites directly.

Phone: +8224042003

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Tisch Cancer Institute (TCI), Icahn School of Medicine
New York, New York 10029-5674
United States
Status: Recruiting Contact: Contact
Thomas Marron, MD, PhD

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