Neoplasms

Blood and Lymph Conditions

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Hematologic Neoplasms

Hematologic Diseases

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.

DT2216 will be administered by intravenous infusion

DT2216

Michael Kurman, MD

A Phase 1, Open-Label, Dose Escalation, and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Clinical Activity of DT2216, an Antiapoptotic Protein Targeted Degradation Compound, in Subjects with Relapsed or Refractory Malignancies

This study is an open-label, first-in-human, dose escalation study in subjects with histologically or cytologically confirmed advanced or metastatic malignancies who are no longer responsive to approved or accepted standard-of-care interventions. The study will consist of a dose escalation phase followed by confirmation of the recommended phase 2 dose (RP2D).

Potentially eligible subjects will undergo screening evaluations (up to 28 days prior to study therapy) and those who meet all protocol-defined eligibility criteria will be enrolled into the study. Subjects who fail screening may be re-screened one time following correction or mitigation of the condition that caused the screen failure; there is no time limit on when a subject may be re-screened. Enrolled subjects will receive a single intravenous (IV) infusion of study drug on Days 1 and 4 weekly for at least 4 weeks, with each cycle consisting of 28 days. Treatment duration for an individual subject may continue for a maximum of 1 year, until disease progression, unacceptable toxicity, subject withdrawal, Investigator's decision for a change in treatment strategy for the individual subject, or death. Longer therapy may be considered for individual subjects upon consultation with the Sponsor's Medical Monitor and overall assessment of benefit:risk. Subjects will be followed for safety for 28 days following the administration of the last study treatment.

A Study of DT2216 in Relapsed/Refractory Malignancies

A Phase 1, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of DT2216, an Antiapoptotic Protein Targeted Degradation Compound, in Patients With Relapsed/Refractory Malignancies

The incidence of adverse events will be the number of subjects with an adverse event divided by the total number subjects.

The severity will be based on the grading of adverse events as described in the CTCAE v5.0

DLT's will be defined by any of the following:

Any Grade 5 toxicity on the CTCAE CTCAE v5.0 Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with clinically significant hemorrhage CTCAE Grade 4 neutropenia lasting \>7 days Febrile Neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3°C (101°F) or a sustained temperature of \>38°C (100.4°F) for \>1 hour Grade 3 thrombocytopenia that is clinically uncomplicated and lasting ≥7 days. CTCAE Grade 4 non-hematologic toxicity of any duration CTCAE Grade 3 non-hematologic toxicity, except nausea, vomiting and/or diarrhea lasting ≤3 days or laboratory abnormalities that return to baseline within ≤3 days with or without medical intervention Changes in liver enzymes consistent with Hy's law indicative of drug-induced hepatocellular injury

The Cmax will be based on blood levels following intravenous administrration of DT2216.

The half-life will be based on blood levels of DT2216 following intravenous administration.

The clearance of DT2216 will be based on blood levels of DT2216 following intravenous administration

Levels of BCL-XL will be measured in peripheral blood mononuclear cells

Platelet counts will be determined at various time points after administration of DT2216

The response rate to DT2216 will be determined at various time points following administration of DT2216 based on the Response Evaluation Criteria in Solid Tumors 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of DT2216 in Relapsed/Refractory Malignancies	NCT04886622	Solid Tumor Hematologic Mal...	DT2216	18 Years -	Dialectic Therapeutics, Inc
A Study of DT2216 in Relapsed/Refractory Malignancies	NCT04886622	Solid Tumor Hematologic Mal...	DT2216	18 Years -	Dialectic Therapeutics, Inc
A Study of DT2216 in Relapsed/Refractory Malignancies	NCT04886622	Solid Tumor Hematologic Mal...	DT2216	18 Years -	Dialectic Therapeutics, Inc

Spots Global Cancer Trial Database for dt2216

Every month we try and update this database with for dt2216 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dt2216

Every month we try and update this database with for dt2216 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dt2216 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.