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Monoclonal Antibodies
ICT01 for Advanced Cancers (EVICTION Trial)
Phase 1 & 2
Recruiting
Research Sponsored by ImCheck Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
EVICTION Trial Summary
This trial will test a new antibody drug, ICT01, either alone or in combination with another drug, pembrolizumab, in patients with advanced solid or blood cancers.
Who is the study for?
This trial is for adults with advanced-stage or recurrent cancers, including various solid tumors and blood cancers. Participants must have a certain level of immune cells (g9d2 T cells), an ECOG performance status ≤ 1, and a life expectancy over 3 months. They should not have rapidly progressing disease, active autoimmune disorders treated with immunosuppressants in the last year, primary/secondary immune deficiencies, uncontrolled infections requiring IV treatment, or recent anti-tumor therapies.Check my eligibility
What is being tested?
The study tests ICT01 as monotherapy and combined with pembrolizumab in patients with advanced cancer. Part 1 escalates doses to find safe levels; Part 2 expands into specific tumor types for further testing. ICT01 targets BTN3A on immune cells to potentially enhance the body's ability to fight cancer.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with monoclonal antibodies such as infusion-related reactions (like fever or chills), fatigue, allergic responses, possible organ inflammation due to an enhanced immune response against the body's own tissues (autoimmunity), and increased susceptibility to infections.
EVICTION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (Parts 1 & 2)
Disease Control Rate using RECIL for lymphoma patients (Part 2)
Disease Control Rate using RECIST for solid tumor patients (Part 2)
Secondary outcome measures
AUC following the first dose of ICT01
Change from Baseline in the Activation State of Circulating Gamma Delta T Cells
Change from Baseline in the Number of Circulating Gamma Delta T Cells
+4 moreEVICTION Trial Design
2Treatment groups
Experimental Treatment
Group I: IV ICT01 MonotherapyExperimental Treatment1 Intervention
Up to six ICT01 dose levels administered as IV monotherapy every 3 weeks will be tested in Part 1 Dose Escalation and up to 2 dose levels in Part 2 Cohort Expansion
Group II: IV ICT01 + IV PembrolizumabExperimental Treatment1 Intervention
A range of IV ICT01 doses administered every 3 weeks will be tested in combination with 200 mg pembrolizumab in Part 1 Dose Escalation and up to 2 dose levels of ICT01 plus 200 mg pembrolizumab in Part 2 Cohort Expansion
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Who is running the clinical trial?
ImCheck TherapeuticsLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Paul Frohna, MD, PhDStudy DirectorImCheck Therapeutics
2 Previous Clinical Trials
126 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had major surgery less than 4 weeks ago.I do not have any ongoing infections needing IV antibiotics or antivirals.I have side effects from past treatments, but they are manageable except for some specific conditions.I haven't taken any cancer drugs in the last 28 days or 5 half-lives, whichever is shorter.I have a condition that weakens my immune system.My cancer originates from Vγ9Vδ2 T cells.You have been diagnosed with advanced or recurrent cancer that falls under certain categories, including bladder, breast, colon, gastric, melanoma, ovarian, prostate, and pancreatic cancer, or certain types of leukemia and lymphoma. You must also meet certain health criteria, such as having a certain level of T cells and a life expectancy of at least three months, and have at least one measurable lesion according to specific evaluation criteria.I have been taking more than 10 mg of prednisone or 2 mg of dexamethasone daily for the last month.I have been on medication for an autoimmune disorder in the past year.My cancer is spreading quickly and is threatening my life.You cannot have taken any experimental medication for the last 28 days before starting this study.
Research Study Groups:
This trial has the following groups:- Group 1: IV ICT01 Monotherapy
- Group 2: IV ICT01 + IV 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.
What is the target outcome of this experimental endeavor?
"This 12-month clinical trial will measure its primary outcome, Disease Control Rate using RECIST for solid tumor patients (Part 2), and several secondary outcomes such as Change from Baseline in the Number of Circulating Gamma Delta T Cells, Half-life of ICT01, and Objective Response Rate using RECIST for solid tumor patients (Part 2)."
Answered by AI
What is the total participant capacity of this clinical trial?
"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting volunteers with the initial posting on February 10th 2020 and most recent update on October 5th 2022. 150 participants are needed from a single location to complete the trial."
Answered by AI
Is enrollment currently open for this experiment?
"Based on what is available through clinicaltrials.gov, this study is still enrolling participants. It was initially posted back in February 10th 2020 and has since been modified as recently as October 5th 2022."
Answered by AI
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