DT2216 for Cancer

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dialectic Therapeutics, Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michael Kurman, MD

Principal Investigator

Dialectic Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

You have tried all available treatments for your cancer, but they have not cured it or are not safe for you to use.

Your heart's ability to pump blood is good, as checked by a heart ultrasound or scan.

You are 18 years old or older and able to provide informed consent.

Exclusion Criteria

Received any BCL-XL directed therapy

Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A)

Your condition is rapidly getting worse or you are expected to live less than 3 months according to the investigator.

Treatment Details

Interventions

• DT2216 (Antiapoptotic Protein Targeted Degradation Compound)

Trial Overview 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).

Participant Groups

Group I: DT2216 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Dialectic Therapeutics, Inc

Lead Sponsor

Trials

1

Recruited

20+