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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.
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
Study 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.Check my eligibility
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.See study design
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.
Select...
I can carry out all my usual activities without help.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 outcome measures
Receptor occupancy of IO-108 in IO-108 monotherapy and IO-108+pembrolizumab
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
Find a Location
Who is running the clinical trial?
Immune-Onc Therapeutics IncLead Sponsor
2 Previous Clinical Trials
306 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,538 Total Patients Enrolled
Immune-Onc TherapeuticsLead Sponsor
3 Previous Clinical Trials
395 Total Patients Enrolled
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there space for participants in this experiment?
"Affirmative. The clinicaltrials.gov website verifies that this medical trial, which was opened on September 30th 2021, is currently recruiting participants. In total, 309 patients need to be enrolled from 7 different healthcare centres."
Answered by AI
Are there numerous medical facilities executing this research project in the city?
"The present medical investigation is enrolling patients from NEXT Oncology-Virginia in Fairfax, Virginia; Gabrail Cancer Center located in Canton, Ohio; MD Anderson Cancer Center situated in Houston, Texas; and 7 other sites."
Answered by AI
How many people have been enrolled in this clinical experiment?
"To complete the trial, 309 participants who meet the eligibility criteria must be enrolled. Regeneron Pharmaceuticals will administer this research from NEXT Oncology-Virginia in Fairfax, Virginia and Gabrail Cancer Center in Canton Ohio."
Answered by AI
To what medical ailments is IO-108 commonly administered?
"IO-108 can be administered to those suffering from malignant neoplasms, inoperable melanoma and microsatellite instability high."
Answered by AI
Could you please enumerate the other research conducted involving IO-108?
"Presently, there are 961 ongoing trials for IO-108 with 122 studies entering Phase 3. Given that 35731 research centres across the nation are conducting investigations into this drug, Houston Texas is unsurprisingly one of many locations offering these clinical trials."
Answered by AI
Has IO-108 achieved regulatory authorization by the FDA?
"Since this is an initial Phase 1 trial, there is limited evidence for the effectiveness and safety of IO-108, thus we gave it a score of 1."
Answered by AI
What are the desired outcomes of this research endeavor?
"The primary goal of this two-year trial is to ascertain the maximum tolerated dose (MTD) by monitoring for any dose-limiting toxicities. Additionally, researchers will investigate immunogenicity with regards to IO-108 and pembrolizumab through a measure of anti-drug antibodies. Data on plasma concentration of IO-108 at peak levels as well as steady state concentrations will also be collected in order to draw meaningful conclusions from the study."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
What site did they apply to?
Providence Cancer Institute
Arizona Oncology Associates, PC-HOPE (140) (USOR SITE)
Texas Oncology - Baylor Charles A. (143) (USOR SITE)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I'm looking for a treatment could help me to find a cure. I tried various chemotherapies and they haven't worked. Looking for different options.
PatientReceived 1 prior treatment
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