Evaluating GI-101 with Pembrolizumab, Lenvatinib, or Radiotherapy in Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A, both as a standalone treatment and in combination with pembrolizumab, lenvatinib, or local radiotherapy, for patients with advanced or metastatic solid tumors. The study is structured into six parts, including dose-escalation and expansion cohorts for both GI-101 and GI-101A, allowing for a comprehensive evaluation of these therapies. Participants will be monitored for anti-tumor effects and any adverse reactions throughout the trial.

Why it matters

Who can join: the full rules

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
* 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/GI-101A, pembrolizumab or lenvatinib.

Other protocol defined inclusion exclusion criteria may apply. Cancer type and part-specific inclusion criteria are described in the study protocol.

Where it's running

• Tisch Cancer Institute (TCI), Icahn School of Medicine
  New York, New York, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting
• Carolina Biooncology Institute
  Huntersville, North Carolina, United States Recruiting
• The Catholic University of Korea Seoul ST.MARY'S Hospital
  Seoul, Banpo-daero, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seoul, Bundang-gu, South Korea Recruiting
• Chungnam National University Hospital
  Daejeon, Daejeon, South Korea Recruiting

Study contacts

• Study coordinator: Recruiting sites have contact information. Please contact the sites directly.
• Email: clinical@gi-innovation.com
• Phone: +8224042003

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.