What side effects are associated with this type of intervention?

Common treatments for blood cancers, particularly those involving targeted therapies like DT2216, often result in side effects such as fatigue, nausea, hyperglycemia, decreased appetite, and diarrhea. Patients may also experience cytopenias, including neutropenia, thrombocytopenia, and anemia. Other potential side effects include antibody formation, mucocutaneous ulcers, peripheral neuropathy, and teratogenicity. Severe toxicities can involve pulmonary issues, gastrointestinal and hepatic problems, and increased infection risk.

What prior FDA approvals exist?

FDA approvals for the treatment of blood cancers have included several drugs targeting apoptosis pathways. For instance, venetoclax, a BCL-2 inhibitor, has been approved for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). Venetoclax works by inhibiting the BCL-2 protein, promoting apoptosis in cancer cells. Other notable approvals include proteasome inhibitors like bortezomib for multiple myeloma, which disrupts protein degradation pathways, leading to cancer cell death. These treatments share a common goal of inducing apoptosis in malignant cells, similar to the mechanism being studied with DT2216.

What other types of research exist?

Promising novel alternatives to DT2216 for blood cancer patients include: 1) Peptide-mediated, B-cell receptor-targeted therapy, which has shown significant anti-tumor effects in Burkitt's lymphoma models. 2) CMC-544 (inotuzumab ozogamicin) combined with rituximab, which has demonstrated enhanced antitumor efficacy in B-cell non-Hodgkin's lymphoma. 3) Recombinant engineered-lactoferrin (rtHLF4), which exhibits up to 100-fold improved anticancer activity compared to full-length lactoferrin. 4) Obinutuzumab-Dianthin conjugates combined with the endosomal escape enhancer SO1861, which have shown improved response rates and overall survival in B-cell non-Hodgkin lymphoma. 5) Mitochondrial targeting domain of NOXA, which induces necrosis in apoptosis-resistant tumor cells.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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 more

Awards & 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

Do I qualify?Apply below to find out

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.