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IO-108 + PD-1 Inhibitors for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Immune-Onc Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be ≥18.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Must not have
Patients who previously received a monoclonal antibody therapy targeting LILRB2/ Immunoglobulin-Like Transcript 4 (ILT4) (including IO-108)
Requires systemic corticosteroids at a dose of >10 mg prednisone or the dose equivalent to other systemic corticosteroid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the second dose of io-108 until the last treatment which is up to 2 years from the first treatment date
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, IO-108, to see if it is safe and effective for treating patients with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors that have not responded to, or cannot receive standard treatments may join this trial. They should be in relatively good health (ECOG status 0-1), have measurable disease, and proper liver and kidney function. Exclusions include serious lung conditions, symptomatic brain tumor spread, severe immune reactions from past immunotherapies, uncontrolled infections including hepatitis B/C and HIV, certain heart issues within the last 6 months, or recent other cancer therapies.
What is being tested?
The study is testing IO-108 alone or combined with PD-1 inhibitors pembrolizumab or cemiplimab in patients with various advanced solid tumors. It aims to determine the safety profile of IO-108, how well it's tolerated by patients when used alone or alongside established immunotherapies and to find an effective dose for future studies.
What are the potential side effects?
Potential side effects could include typical reactions seen with immunotherapy such as fatigue, skin reactions, inflammation of organs like lungs (pneumonitis) or intestines (colitis), potential infusion-related symptoms during treatment administration and possible immune system overactivity leading to autoimmune-like conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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I can carry out all my usual activities without help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously received a specific antibody therapy for my condition.
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I need more than 10 mg of prednisone or its equivalent daily.
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I have had lung inflammation or scarring not caused by an infection.
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My cancer has spread to my brain and is causing symptoms.
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I have had severe side effects from previous immunotherapy.
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I do not have any ongoing, untreated infections.
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I do not have serious heart rhythm problems.
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I do not have any active infections like HBV, HCV, HIV, COVID-19, or AIDS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the second dose of io-108 until the last treatment which is up to 2 years from the first treatment date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the second dose of io-108 until the last treatment which is up to 2 years from the first treatment date
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neoplasms
Determine MTD (maximum tolerated dose) through assessment of dose-limiting toxicities (DLT)
Incidence of treatment-emergent and serious adverse events in patients treated with IO-108 and IO-108+pembrolizumab
Secondary study objectives
Anti-tumor activity of IO-108 and IO-108+pembrolizumab
Determine disease control rates of IO-108 as monotherapy or in combination with either pembrolizumab or cemiplimab
Immunogenicity of IO-108 and IO-108+pembrolizumab
+2 moreOther study objectives
Receptor occupancy of IO-108 in IO-108 monotherapy and IO-108+pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: IO-108 MonotherapyExperimental Treatment1 Intervention
Treatment of patients with advanced solid tumors with IO-108 monotherapy
Group II: IO-108 + pembrolizumab combination therapyExperimental Treatment1 Intervention
Treatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of pembrolizumab
Group III: IO-108 + cemiplimab combination therapyExperimental Treatment1 Intervention
Treatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of cemiplimab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IO-108
2022
Completed Phase 1
~130
IO-108 + pembrolizumab combination therapy
2021
Completed Phase 1
~100
IO-108 + cemiplimab combination therapy
2021
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Immune-Onc Therapeutics IncLead Sponsor
2 Previous Clinical Trials
128 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,733 Total Patients Enrolled
Immune-Onc TherapeuticsLead Sponsor
4 Previous Clinical Trials
684 Total Patients Enrolled
Luke Chung, MD, MPHStudy DirectorImmune-Onc Therapeutics
1 Previous Clinical Trials
22 Total Patients Enrolled
Wen Hong Lin, MDStudy DirectorImmune-Onc Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver and kidneys are working well.I do not have any ongoing, untreated infections.I have had lung inflammation or scarring not caused by an infection.My cancer has spread to my brain and is causing symptoms.I have had severe side effects from previous immunotherapy.My heart's pumping ability is significantly reduced.I have no active cancer except for certain skin cancers, low-risk prostate cancer, or any treated cancer with no treatment in the last 6 months.I haven't had major heart or stroke issues in the last 6 months.I do not have serious heart rhythm problems.I do not have any active infections like HBV, HCV, HIV, COVID-19, or AIDS.I am 18 years old or older.I have an advanced cancer that has spread, and standard treatments haven't worked or aren't suitable for me.I can carry out all my usual activities without help.I have previously received a specific antibody therapy for my condition.I haven't had cancer treatment or fully recovered from its side effects recently.I need more than 10 mg of prednisone or its equivalent daily.I am 18 years old or older.I have an advanced cancer that has spread, and standard treatments haven't worked or aren't suitable for me.I am fully active or restricted in physically strenuous activity but can do light work.My liver and kidneys are working well.
Research Study Groups:
This trial has the following groups:- Group 1: IO-108 + cemiplimab combination therapy
- Group 2: IO-108 Monotherapy
- Group 3: IO-108 + pembrolizumab combination therapy
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.
Solid Tumors Patient Testimony for trial: Trial Name: NCT05054348 — Phase 1