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)

Launched by GI INNOVATION, INC. · Apr 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GI-102 for patients with advanced solid tumors, which are cancers that have spread beyond their original site. The main goal of the study is to see how safe GI-102 is and how well it works on its own for people dealing with these types of cancers. The trial is currently looking for participants aged 18 and older, who are in good health overall and have measurable cancer that has not responded to other treatments.

If you or someone you know is considering participating, it’s important to know that certain health conditions may affect eligibility. For example, potential participants should not have active brain tumors, certain infections, or a history of specific liver diseases. During the trial, participants will receive GI-102 and will be monitored closely for any side effects or reactions while the researchers gather information about the drug's effectiveness. Overall, this study aims to provide valuable insights into a potential new option for treating advanced cancers.

Gender

ALL

Eligibility 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-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.
• • Other protocol defined inclusion exclusion criteria may apply