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Monoclonal Antibodies
EOS-448 for Cancer (TIG-006 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by iTeos Belgium SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Part 2 (H&N cancer): Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until disease progression - approximately 48 months
Awards & highlights
TIG-006 Trial Summary
This trial is testing a new drug, EOS-448, to see if it is safe and effective against advanced solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors, including melanoma, lung cancer, and head & neck cancers. Participants must have progressed on anti-PD-(L)1 therapy (for melanoma), or be eligible for first-line metastatic treatment combining anti-PD(L)1 therapy with chemotherapy. They should not have received recent anticancer therapies or live vaccines, nor should they have uncontrolled diseases or certain genetic aberrations indicating other treatments.Check my eligibility
What is being tested?
The study tests EOS-448 combined with standard care and/or investigational drugs in patients with advanced tumors. It's an open-label phase I/II trial to assess safety, dosage, how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and its ability to fight tumors.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation of organs, infusion-related reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body's resources, digestive issues like nausea or diarrhea due to gastrointestinal tract involvement by drugs.
TIG-006 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My head and neck cancer cannot be cured with surgery or radiation.
Select...
My cancer is advanced or has spread, and there are no standard treatments left.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
My lung cancer is at stage III or IV and cannot be cured with surgery or chemoradiotherapy.
TIG-006 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until disease progression - approximately 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression - approximately 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with DLT and Adverse Events
Percentage of participants with Objective Response as determined by Investigator
Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level
+2 moreOther outcome measures
Change from baseline in absolute cell count in the tumor and in peripheral blood
Frequency of activation/exhaustion markers in the tumor and in peripheral blood
TIG-006 Trial Design
9Treatment groups
Experimental Treatment
Group I: Part 2D - EOS-448 + dostarlimabExperimental Treatment2 Interventions
Participants with 1L mHNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle
Group II: Part 2C - EOS-448 + dostarlimabExperimental Treatment2 Interventions
Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
Group III: Part 1G - EOS-448 + dostarlimab + chemotherapiesExperimental Treatment3 Interventions
Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
Group IV: Part 1F - EOS-448 + dostarlimab + inupadenant HCExperimental Treatment3 Interventions
Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis
Group V: Part 1E - inupadenant HCl + dostarlimabExperimental Treatment2 Interventions
Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis
Group VI: Part 1D - EOS-448 + dostarlimabExperimental Treatment2 Interventions
Participants will receive EOS-448 and dostarlimab at every cycle
Group VII: Part 1C - EOS-448 + inupadenantExperimental Treatment2 Interventions
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Group VIII: Part 1B - EOS-448 + inupadenantExperimental Treatment2 Interventions
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Group IX: Part 1A - EOS-448 + pembrolizumabExperimental Treatment2 Interventions
Participants will receive EOS-448 and pembrolizumab at every cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
iTeos Belgium SALead Sponsor
5 Previous Clinical Trials
538 Total Patients Enrolled
iTeos TherapeuticsIndustry Sponsor
7 Previous Clinical Trials
1,143 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,434 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My head and neck cancer cannot be cured with surgery or radiation.My brain metastases have been treated and stable for over a month.My cancer is advanced or has spread, and there are no standard treatments left.I have not received a live vaccine in the last 30 days.I have been diagnosed with a primary brain cancer.I have had immunotherapy for my head and neck cancer.I haven't had any cancer treatment in the last 4 weeks.I have head and neck cancer and received chemotherapy for advanced stages less than 6 months ago.I had another type of cancer but have been in complete remission for at least 2 years.My side effects from previous cancer treatments have mostly gone away or are mild.I have had severe lung inflammation or ongoing immune-related side effects from previous treatments.My organs are functioning well.I had radiotherapy less than 2 weeks before starting the study treatment.I have not had major surgery in the last 3 weeks.I have serious heart problems that are not under control.I am fully active or have some restrictions but can still care for myself.I am eligible for a combination of immunotherapy and chemotherapy as my first treatment for advanced lung cancer.My lung cancer is at stage III or IV and cannot be cured with surgery or chemoradiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1F - EOS-448 + dostarlimab + inupadenant HC
- Group 2: Part 1A - EOS-448 + pembrolizumab
- Group 3: Part 1E - inupadenant HCl + dostarlimab
- Group 4: Part 1D - EOS-448 + dostarlimab
- Group 5: Part 2D - EOS-448 + dostarlimab
- Group 6: Part 1C - EOS-448 + inupadenant
- Group 7: Part 1G - EOS-448 + dostarlimab + chemotherapies
- Group 8: Part 2C - EOS-448 + dostarlimab
- Group 9: Part 1B - EOS-448 + inupadenant
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
What cancers does Anti-PD1 therapy typically fight against?
"Anti-PD1 is a frequently used medication to treat malignant neoplasms. However, it can also help patients that have unresectable melanoma, microsatellite instability high, and those that have experienced disease progression after chemotherapy."
Answered by AI
What are the most recent findings regarding Anti-PD1?
"Currently, there are 1000 ongoing clinical trials studying Anti-PD1 with 122 trials in Phase 3. While many of the trials for Anti-PD1 are based in Houston, Texas, there are 36030 locations operating trials for Anti-PD1."
Answered by AI
Are there any available positions for new participants in this research?
"According to the latest update on clinicaltrials.gov, this trial is still recruiting patients. This particular study was posted on September 6th 2021 and has been updated as recently as June 13th 2022."
Answered by AI
How many people are in this clinical trial?
"The listing on clinicaltrials.gov does show that the trial is ongoing and currently looking for volunteers. According to the information available, the study was initially posted on September 6th 2021. The most recent update was made on June 13th 2022. So far, 1 site has been identified but 376 participants are needed in total."
Answered by AI
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