Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

Official Title

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

Summary:

The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR)
Secondary Outcome:
  • Duration of Response (DOR)
  • Complete Response (CR) Rate
  • Relapse-Free Survival (RFS)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Fraction of Participants Who Receive Hematopoietic Stem Cell Transplant (HSCT)
  • Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)
  • Number of Participants Who Experience At Least One Serious Adverse Event (SAE)
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECGs) Results
  • Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Time to Reach Maximum Plasma Concentration (Tmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Clearance (CL) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Volume of Distribution (Vd) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199
  • Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses
  • Number of Participants With At Least One ADA Titer
  • Number of Participants With Neutralizing Antibodies To Camidanlumab Tesirine Following Treatment With Camidanlumab Tesirine
  • Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
  • Change from Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
This is a phase 2, multi-centre, open-label, single-arm study of efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin lymphoma. This study will enroll approximately 100 participants. Camidanlumab Tesirine (ADCT-301) is an antibody drug conjugate (ADC), composed of the human monoclonal antibody, HuMax®-TAC, which is directed against human CD25. The antibody is conjugated through a protease cleavable linker to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxin. For each participant the study will include a screening period (of up to 28 days), a treatment period (cycles of 3 weeks), and a follow-up period (approximately every 12-week visits) for up to 3 years after treatment discontinuation. Participants may continue treatment for up to 1 year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first. Additionally, patients benefiting clinically at 1 year may continue treatment after a case by case review with the Sponsor.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society