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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
Has exhausted all curative options or has a contraindication to approved therapies or generally recognized standard-of-care measures for the subject's cancer.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have tried all available treatments for your cancer, but they have not cured it or are not safe for you to use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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 more

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

Find a Location

Who is running the clinical trial?

Dialectic Therapeutics, IncLead Sponsor
Michael Kurman, MDStudy DirectorDialectic Therapeutics
9 Previous Clinical Trials
504 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment currently enrolling patients?

"Affirmative, the clinical trial is actively seeking participants. According to records stored on clinicialtrials.gov, this study was originally posted in August of 2021 and last updated in July 2022. In total, 24 individuals are expected to participate from 3 different medical locations."

Answered by AI

What key objectives is this experiment hoping to accomplish?

"As declared by the clinical trial sponsor, Dialectic Therapeutics Inc., the primary objective of this 28 day experiment is to measure dose-limiting toxicity (DLT) in patients administered DT2216. Additionally, secondary objectives include gaining insight into platelet counts after administration of DT2216 and measuring Cmax levels and BCL-XL concentrations in peripheral blood mononuclear cells."

Answered by AI

How many participants are currently enrolled in this clinical experiment?

"Affirmative. Records from clinicaltrials.gov demonstrate that the study, which was launched on August 25th 2021 and last revised on July 27th 2022, is presently recruiting participants from 3 distinct locations with a goal of 24 enrollees."

Answered by AI

Has the FDA officially sanctioned DT2216 for clinical use?

"As this is an early phase 1 trial, there is still limited evidence of DT2216's efficacy and safety. As such, the Power team have assigned it a score of 1 on the scale from one to three."

Answered by AI
~6 spots leftby Mar 2025