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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HLA-A*02:01 positive
Eastern Cooperative Oncology Group (ECOG) performance status (ECOG PS) 0 or 1
Must not have
Ongoing treatment with systemic steroids or other immunosuppressive therapies
Significant secondary malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Awards & highlights
Summary
"This trial is testing a new antibody called CDR404 for treating certain cancers that have a specific marker called MAGE-A4. The study aims to see if CDR404 is safe and effective in
Who is the study for?
This trial is for adults with certain advanced solid tumors that show the MAGE-A4 marker and have the HLA-A*02:01 tissue type. Participants must be in good physical condition, have relapsed or not responded to standard treatments, and have measurable disease. They should also have proper organ function and agree to use effective contraception if applicable.
What is being tested?
CDR404, a new antibody designed to target cancers expressing the MAGE-A4 antigen, is being tested for safety and effectiveness. This first-in-human study will assess how well CDR404 works against these specific tumors in participants with the right genetic markers.
What are the potential side effects?
As this is a first-in-human study of CDR404, potential side effects are not yet fully known but may include typical reactions related to immune-based cancer therapies such as fatigue, fever, allergic reactions or autoimmune-like conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HLA-A*02:01 positive.
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I am fully active or have some restrictions but can still care for myself.
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My condition did not improve with standard treatments.
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My tumor is MAGE-A4 positive.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking steroids or other drugs that weaken my immune system.
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I have another serious cancer besides the one being treated.
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I do not have any uncontrolled illnesses.
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I have brain metastases that are causing symptoms or have not been treated.
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I recently had cancer treatment and haven't waited long enough to start a new one.
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I am still experiencing major side effects from my previous cancer treatment.
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I have a serious heart condition.
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I am at risk for AIDS due to my HIV status.
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I have active hepatitis B or C.
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I have an autoimmune disease that needs ongoing treatment.
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I am currently on antibiotics for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-tumor response: Overall Response Rate (ORR)
Incidence and severity of (serious) adverse events ([S]AEs)
Presence of dose limiting toxicities (DLTs)
Secondary outcome measures
Accumulation ratio of CDR404 (Rac)
Area under the CDR404 serum concentration over time curve (AUC0-T)
Average serum concentration of CDR404 (Cavg)
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CDR404Experimental Treatment1 Intervention
Dose escalation
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Who is running the clinical trial?
CDR-Life AGLead Sponsor
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