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Antiapoptotic Protein Targeted Degradation Compound
DT2216 for Cancer
Phase 1
Waitlist Available
Research Sponsored by Dialectic Therapeutics, Inc
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 one year
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new drug for cancer patients who have not responded to other treatments.
Who is the study for?
Adults aged 18+ with relapsed or refractory malignancies, who have tried all curative options or can't use standard treatments. They must have a heart function test showing ≥50% ejection fraction, good organ function including specific blood counts and liver enzymes, not be pregnant or breastfeeding, and agree to contraception. Exclusions include significant liver issues, certain drug interactions, recent major surgery or therapy, active infections like hepatitis B/C or HIV, known allergies to study drugs components.Check my eligibility
What is being tested?
DT2216 is being tested for safety and effectiveness in treating various cancers that haven't responded to other treatments. This Phase 1 trial involves gradually increasing doses of DT2216 to find the highest dose patients can take without serious side effects (dose escalation), followed by giving this dose to more patients (cohort expansion).See study design
What are the potential side effects?
Specific side effects are not listed but generally may include reactions at the infusion site where the drug enters the body through a vein; changes in blood counts leading to increased risk of infection; fatigue; nausea; liver enzyme alterations affecting liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of subjects with adverse events based on the Common Terminology Criteria for Adverse Evens (CTCAE) v5.0 following treatment with DT2216.
The number of subjects with adverse events of different grades based on the CTCAE v5.0
The number of subjects with dose limiting toxicity (DLT) of DT2216.
Secondary outcome measures
The measurement of Cmax of DT2216 following intravenous administration
The measurement of levels of BCL-XL in peripheral blood mononuclear cells
The measurement of platelet counts following administration of DT2216
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: DT2216Experimental Treatment1 Intervention
DT2216 will be administered by intravenous infusion over 30 minutes twice weekly on a continuous basis. Each treatment cycle will be 28 days in duration. The starting dose of DT2216 will be 0.04 mg/kg and will escalate by 100% increments for the first 5 treatment groups. Thereafter, if additional dose escalations are required, escalation will follow a modified Fibonacci scheme. Treatment may continue for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DT2216
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Dialectic Therapeutics, IncLead Sponsor
Michael Kurman, MDStudy DirectorDialectic Therapeutics
9 Previous Clinical Trials
445 Total Patients Enrolled
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