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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1, assessed up to approximately 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or can carry out light work.
Select...
My side effects from previous cancer treatments have mostly gone away.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study day 1, assessed up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1, assessed up to approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreOther outcome measures
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)
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
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,665 Total Patients Enrolled
31 Trials studying Sarcoma
3,497 Patients Enrolled for Sarcoma
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are functioning well.I have not had immunotherapies similar to GI-101.I have or had Hepatitis B, or I currently have Hepatitis C.I have a history of liver disease but not due to cancer spread.I am fully active or can carry out light work.I have not received a live vaccine in the last 4 weeks.I am 18 years or older, or meet the age requirement in my area.I haven't had radiotherapy in the last 2 weeks, except for palliative care.I have active tuberculosis or a history of it.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last 2 weeks.My side effects from previous cancer treatments have mostly gone away.I have active brain metastases or cancer in the lining of my brain.You are allergic to any parts of the drugs GI-101, pembrolizumab, or lenvatinib.I am HIV positive, on ART, and my HIV is well-controlled.I have another type of cancer that is currently active.I do not have any current severe infections or ones that were not controlled in the last 4 weeks.Your disease can be measured using a specific guideline called RECIST v1.1.I have been treated for an autoimmune disease in the last 2 years.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: GI-101 + Pembrolizumab
- Group 2: GI-101
- Group 3: GI-101A
- Group 4: GI-101 + Lenvatinib
- Group 5: GI-101 + Local Radiotherapy
- Group 6: GI-101A + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings left for this research trial?
"As seen on clinicaltrials.gov, recruitment for this medical experiment is ongoing; the trial was first posted online in July 2021 and it’s most recent edit occurred on February 5th 2023."
Answered by AI
What is the upper limit for patient enrollment in this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this research trial, which was initially posted on 7/23/2021, is currently enrolling participants. The total desired recruitment size stands at 374 patients from 1 medical site."
Answered by AI
What other experiments involving GI-101 combined with Local Radiotherapy have been carried out?
"Presently, there are 983 ongoing clinical trials that focus on GI-101 + Local Radiotherapy with 131 of these being at the third stage. Although a considerable number of studies for this combination therapy take place in San Diego, California; altogether 37131 sites are researching GI-101 + Local Radiotherapy."
Answered by AI
What medical condition does the combination of GI-101 and Local Radiotherapy typically address?
"GI-101 + Local Radiotherapy is widely used as a course of action for malignant neoplasms, unresectable melanoma, microsatellite instability high cases, and post chemotherapy progression."
Answered by AI
What results is this clinical trial seeking to obtain?
"According to the study's sponsor, Merck Sharp & Dohme LLC, Objective Response Rate (ORR) will be the primary outcome measure. It is assessed over a 24-month period and based on RECIST version 1.1 observations. Secondary outcomes include Time to Tumor Response (TTR), Progression-Free Survival (PFS), and Half-life of GI-101 (T1/2). All these parameters are evaluated through detailed radiographic imaging reports by investigators."
Answered by AI
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