NCT04886622

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dialectic Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Solid Tumor
• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	DT2216	DT2216 will be administered by intravenous infusion

Timeline

• Start date: 2021-08-25
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2021-05-14
• Last updated: 2025-04-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study