RECRUITING

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.

Official Title

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

Quick Facts

Study Start:2023-05-30
Study Completion:2027-04-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05824975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
  2. * Has adequate organ and marrow function as defined in protocol.
  3. * Measurable disease as per RECIST v1.1.
  4. * ECOG performance status 0-1.
  5. * 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.
  6. * HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol.
  1. * Has known active CNS metastases and/or carcinomatous meningitis.
  2. * An active second malignancy.
  3. * Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.
  4. * Has active tuberculosis or has a known history of active tuberculosis.
  5. * Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.
  6. * History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.
  7. * Has an active autoimmune disease that has required systemic treatment in past 2 years.
  8. * Previous immunotherapies related to mode of action of GI-102.
  9. * 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.
  10. * Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
  11. * Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy.
  12. * Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
  13. * Known hypersensitivity to any of the components of the drug products and/or excipients of GI-102.

Contacts and Locations

Study Contact

Jay Kim
CONTACT
+82-2-404-2003
Clinical-102@gi-innovation.com
Woosun Lee
CONTACT
+82-2-404-2003
Clinical-102@gi-innovation.com

Principal Investigator

Nari Yun, PhD
STUDY_DIRECTOR
GI Innovation, Inc.

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Mayo Clinic in Minnesota
Rochester, Minnesota, 55905
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: GI Innovation, Inc.

  • Nari Yun, PhD, STUDY_DIRECTOR, GI Innovation, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-30
Study Completion Date2027-04-24

Study Record Updates

Study Start Date2023-05-30
Study Completion Date2027-04-24

Terms related to this study

Keywords Provided by Researchers

  • GI-102
  • CD80-IgG4 Fc-IL2 variant
  • Immunotherapy
  • IL-2
  • Interleukin-2
  • bispecific protein
  • immunocytokine
  • CD80
  • CTLA-4
  • Pembrolizumab
  • T-DXd
  • Trastuzumab deruxtecan
  • Doxorubicin
  • Paclitaxel
  • Bevacizumab
  • Eribulin

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Soft Tissue Sarcoma (STS)
  • Platinum-resistant Ovarian Cancer (PROC)
  • Hepatocellular Carcinoma (HCC)
  • Colorectal Cancer (CRC)
  • HER2 Negative Breast Cancer
  • Cutaneous Melanoma
  • Renal Cell Carcinoma (RCC)