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)

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.

Conditions

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)

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Study Overview

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Study Details

Study overview

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.

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)

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)

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Rochester

Mayo Clinic in Minnesota, Rochester, Minnesota, United States, 55905

New York

Memorial Sloan-Kettering Cancer Center, New York, New York, United States, 10065

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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-102.
  • * 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.
  • * 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-102.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GI Innovation, Inc.,

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

Study Record Dates

2027-04-24