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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
No Placebo-Only Group
Summary
This trial is testing a new drug called DT2216 in patients with advanced cancers that haven't responded to other treatments. DT2216 works by breaking down proteins that help cancer cells survive, potentially helping to kill these cells. DT2216 was developed to reduce the toxicity of its predecessor.
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.
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).
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for blood cancers often involve targeted therapies that disrupt specific cellular processes critical for cancer cell survival. For example, DT2216 targets antiapoptotic proteins, leading to their degradation and promoting cancer cell death.
This mechanism is crucial as it directly interferes with the cancer cells' ability to evade programmed cell death, a common trait in malignancies. Other treatments include chemotherapy, which kills rapidly dividing cells, and immunotherapy, which enhances the body's immune response against cancer cells.
Targeted molecular therapies, such as tyrosine kinase inhibitors, block specific enzymes involved in cancer cell growth and survival. These treatments are significant for blood cancer patients as they offer more precise and potentially less toxic options compared to traditional therapies.
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Who is running the clinical trial?
Dialectic Therapeutics, IncLead Sponsor
Michael Kurman, MDStudy DirectorDialectic Therapeutics
9 Previous Clinical Trials
445 Total Patients Enrolled