A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy

Official Title

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of DCLL9718S in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Patients With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy

Summary:

This Phase Ia/Ib, open-label, multicentre study will evaluate the safety, tolerability, and preliminary efficacy of DCLL9718S as a single agent (Phase Ia, Arm A) in participants with relapsed or refractory AML or in combination with azacitidine (Phase Ib, Arm B) in participants with previously untreated AML who are not eligible for intensive induction chemotherapy. Each arm will consist of two stages: a dose-escalation stage and an expansion stage. The dose-escalation stage is designed to establish the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for DCLL9718S alone (Arm A) or in combination with azacitidine (Arm B). The dose-expansion stage is designed to characterize the long-term safety and tolerability of DCLL9718S.

Trial Description

Primary Outcome:

  • Percentage of participants With Adverse Events (AEs)
  • Percentage of Participants With Dose-Limiting Toxicities (DLTs)
  • MTD of DCLL9718S
  • RP2D of DCLL9718S
Secondary Outcome:
  • Serum Concentration of DCLL9718S
  • Plasma Concentration of Azacitidine
  • Area Under the Concentration-Time Curve (AUC) of DCLL9718S
  • Maximum Plasma Concentration Observed (Cmax) of DCLL9718S
  • Total Clearance of DCLL9718S
  • Terminal Half-Life (t1/2) of DCLL9718S
  • Volume of Distribution Under Steady-State (Vss) of DCLL9718S
  • Percentage of Participants With Complete Remission (CR), CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Count Recovery (CRp), and Overall Response, Assessed as per International Working Group (IWG) Criteria
  • Duration of Response, Assessed as per IWG Criteria
  • Overall Survival
  • Event-Free Survival (EFS), Assessed as per IWG Criteria
  • Progression-Free Survival (PFS), Assessed as per IWG Criteria
  • Change From Baseline in Anti-Drug Antibody (ADA) to DCLL9718S

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society