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Virus Therapy

GI-101 Combination Therapies for Advanced Cancer

Phase 1 & 2
Recruiting
Research Sponsored by GI Innovation, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Previous immunotherapies related to mode of action of GI-101
Has active or a known history of Hepatitis B or known active Hepatitis C virus infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1, assessed up to approximately 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trialwill assess the safety & effectiveness of GI-101 alone or with other treatments in advanced/metastatic solid tumors.

Who is the study for?
Adults with various advanced solid tumors who have good organ and marrow function, an ECOG performance status of 0-1, and controlled HIV (if applicable). They must not have had recent cancer treatments or certain infections, active CNS metastases, a second malignancy, liver disease (except liver metastasis), autoimmune diseases requiring treatment in the last 2 years, known drug hypersensitivities, active tuberculosis or immunodeficiency.
What is being tested?
The trial is testing GI-101/GI-101A alone or combined with pembrolizumab (an immunotherapy), lenvatinib (a targeted therapy), or local radiotherapy. It aims to assess safety and effectiveness across a range of advanced cancers by measuring how well these treatments work together.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in different organs, infusion-related reactions from the drugs given through veins, fatigue from treatment burden on the body's energy resources, digestive issues like nausea or diarrhea due to medication effects on gastrointestinal tract.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My side effects from previous cancer treatments have mostly gone away.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had immunotherapies similar to GI-101.
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I have or had Hepatitis B, or I currently have Hepatitis C.
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I have not received a live vaccine in the last 4 weeks.
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I have active tuberculosis or a history of it.
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I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last 2 weeks.
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I have active brain metastases or cancer in the lining of my brain.
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I have another type of cancer that is currently active.
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I have been treated for an autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1, assessed up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 1, assessed up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and nature of Dose-Limiting Toxicity (DLTs)
Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs)
Objective Response Rate (ORR) according to RECIST version 1.1
Secondary study objectives
Area under the plasma concentration versus time curve (AUC) of GI-101/GI-101A
DCR per iRECIST guidelines
Disease control rate (DCR) according to RECIST version 1.1
+6 more
Other study objectives
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Incidence of anti-GI-101/GI-101A antibody (ADA) and neutralizing antibody (Nab)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: GI-101A + PembrolizumabExperimental Treatment2 Interventions
Dose escalation: GI-101A, multiple ascending doses Dose expansion:
Group II: GI-101AExperimental Treatment1 Intervention
Dose escalation: GI-101A, multiple ascending doses Dose expansion:
Group III: GI-101 + PembrolizumabExperimental Treatment2 Interventions
Dose escalation: GI-101, multiple ascending doses Dose expansion:
Group IV: GI-101 + Local RadiotherapyExperimental Treatment2 Interventions
Dose optimization: Dose expansion:
Group V: GI-101 + LenvatinibExperimental Treatment2 Interventions
Dose optimization: Dose expansion:
Group VI: GI-101Experimental Treatment1 Intervention
Dose escalation: GI-101, multiple ascending doses Dose expansion:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2017
Completed Phase 4
~2070
Pembrolizumab (KEYTRUDA®)
2017
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,004 Previous Clinical Trials
5,184,970 Total Patients Enrolled
4 Trials studying Esophageal Carcinoma
922 Patients Enrolled for Esophageal Carcinoma
GI Innovation, Inc.Lead Sponsor
1 Previous Clinical Trials
92 Total Patients Enrolled
Nari Yun, PhDStudy DirectorGI Innovation
1 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

GI-101 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04977453 — Phase 1 & 2
Esophageal Carcinoma Research Study Groups: GI-101 + Pembrolizumab, GI-101, GI-101A, GI-101 + Lenvatinib, GI-101 + Local Radiotherapy, GI-101A + Pembrolizumab
Esophageal Carcinoma Clinical Trial 2023: GI-101 Highlights & Side Effects. Trial Name: NCT04977453 — Phase 1 & 2
GI-101 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04977453 — Phase 1 & 2
~88 spots leftby Oct 2025
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