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NCT04977453 | RECRUITING | Advanced Solid Tumor

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

Condition or disease

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

Intervention/treatment

GI-101

Pembrolizumab (KEYTRUDA®)

Lenvatinib

Local Radiotherapy

GI-101A

Phase

PHASE1

PHASE2

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)

Study Type : INTERVENTIONAL
Estimated Enrollment : 430 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2021-08-02
Estimated Primary Completion Date : 2026-10
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
GI-101 as a Single Agent or in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Advanced Solid Tumors

Location Details

NCT04977453

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Tisch Cancer Institute (TCI), Icahn School of Medicine

New York, New York, United States, 10029-5674

RECRUITING

United States, North Carolina

Carolina Biooncology Institute

Huntersville, North Carolina, United States, 28078

RECRUITING

South Korea, Daejeon

Chungnam National University Hospital

Daejeon, Daejeon, South Korea, 65015

RECRUITING

South Korea, Allied them

The Catholic University of Korea St. Vincent's Hospital

Suwon, Close them, South Korea, 16247

RECRUITING

South Korea, Seongbuk-gu

Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea, 02841

RECRUITING

South Korea,

Yonsei University Health System, Severance Hospital

Seoul, South Korea, 03722

RECRUITING

South Korea,

Yonsei University Health System, Severance Hospital

Seoul, South Korea, 03722

RECRUITING

South Korea,

Asan Medical Center

Seoul, South Korea, 05505