Study on GI-101 Alone or with Pembrolizumab, Lenvatinib, or Local Radiotherapy for Advanced Solid Tumors

Sponsor: GI Innovation, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04977453

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, GI-101, used alone or with other treatments like pembrolizumab, lenvatinib, or local radiotherapy, in patients with advanced solid tumors.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective GI-101 and its advanced version, GI-101A, are when used alone or combined with other treatments such as pembrolizumab, lenvatinib, or local radiotherapy. It focuses on patients with advanced or metastatic solid tumors to see how well these treatments work and how the body processes them.

Description

This study is divided into six parts and is designed to test the safety and effectiveness of GI-101 and GI-101A, which are new types of drugs. These drugs are being tested alone and in combination with other treatments like pembrolizumab, lenvatinib, or local radiotherapy in patients with advanced solid tumors.

  • Part A: Tests different doses of GI-101 alone.
  • Part B: Tests different doses of GI-101 with pembrolizumab.
  • Part C: Tests different doses of GI-101 with lenvatinib.
  • Part D: Tests different doses of GI-101 with local radiotherapy.
  • Part E: Tests different doses of GI-101A alone.
  • Part F: Tests different doses of GI-101A with pembrolizumab.

GI-101 and GI-101A are special proteins designed to help the immune system fight cancer. GI-101A is an improved version of GI-101 for better manufacturing consistency. The study will help determine the best dose and combination of these treatments for future research.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older (or 19 years depending on local guidelines).
  • Must have good organ and bone marrow function.
  • Must have measurable cancer as per specific medical criteria.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Any side effects from previous cancer treatments must have improved to a mild level, except for hair loss and mild nerve damage.
  • HIV-positive patients must be on treatment and have well-controlled HIV.

Exclusion Criteria

  • Have active cancer spread to the brain or spinal fluid.
  • Have another active cancer.
  • Have active or past Hepatitis B or active Hepatitis C infection.
  • Have active or past tuberculosis.
  • Have active or uncontrolled infections or severe infection within the last 4 weeks.
  • Have chronic liver disease or liver scarring, except if caused by cancer spread.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have had previous treatments similar to GI-101.
  • Have an immune deficiency or are on long-term steroid or immune-suppressing medications.
  • Have had cancer treatment or investigational drugs within the last 4 weeks.
  • Have had radiotherapy within the last 2 weeks, except for limited palliative treatment.
  • Have had a live vaccine within the last 4 weeks.
  • Have allergies to any components of the study drugs.

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