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