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Relapsed Hodgkin LymphomaPhase 2NCT04052997

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

A Phase 2 study testing Camidanlumab Tesirine in people with Relapsed Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, run by ADC Therapeutics S.A. at 73 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Camidanlumab Tesirine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
73 sitesin 11 countries
Study dates
13 Sep 2019to 19 Jan 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Written informed consent must be obtained prior to any procedures.
  • Male or female participant aged 18 years or older. (16 years or older at US based sites)
  • Pathologic diagnosis of classical Hodgkin lymphoma (cHL).
  • Patients with relapsed or refractory cHL, who have received at least 3 prior lines of systemic therapy (or at least 2 prior lines in HSCT ineligible patients) including brentuximab vedotin and a checkpoint inhibitor approved for cHL (e.g., nivolumab or pembrolizumab). Note 1: Receipt of HSCT to be included in the number of prior therapies needed to meet eligibility.
  • Measurable disease as defined by the 2014 Lugano Classification.
  • Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available).
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  • Note 1: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
  • Note 2: If a sufficient amount of tissue is not available, a fresh biopsy may be taken, provided the procedure is not deemed high-risk and is clinically feasible, and provided it is approved locally.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Adequate organ function as defined by Screening laboratory values within the following parameters:
  • Absolute neutrophil count (ANC) ≥ 1.0 × 103/μL (off growth factors at least 72 h).
  • Platelet count ≥ 75 × 103/μL without transfusion in the past 2 weeks.
  • ALT, AST, or GGT ≤ 2.5 × the upper limit of normal (ULN) if there is no liver involvement; ALT or AST ≤ 5 × ULN if there is liver involvement.
  • Total bilirubin ≤ 1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤ 3 × ULN with direct bilirubin ≤ 1.5 × ULN).
  • Blood creatinine ≤ 3.0 × ULN or calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault equation.
  • Note: A laboratory assessment may be repeated a maximum of two times during the Screening Period to confirm eligibility.
  • Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
  • Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9.5 months after the last dose of Camidanlumab Tesirine. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6.5 months after the participants receives his last dose of Camidanlumab Tesirine.

Who cannot join

  • Previous treatment with Camidanlumab Tesirine.
  • Participation in another investigational interventional study. Being in follow-up of another investigational study is allowed.
  • Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD25 antibody.
  • Allogenic or autologous transplant within 60 days prior to start of study drug.
  • Active graft-versus-host disease (GVHD), except for non-neurologic symptoms as a manifestation of mild (≤ Grade 1) chronic GVHD.
  • Post-transplantation lymphoproliferative disorders.
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  • Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary.
  • History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]) (subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
  • History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
  • History of recent infection (within 4 weeks of Cycle 1, Day 1 [C1D1]) considered to be caused by one of the following pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
  • Note: An influenza test and a pathogendirected SARS CoV-2 test (such as polymerase chain reaction) are mandatory and must be negative before initiating study treatment (tests to be performed 3 days or less prior to dosing on C1D1; an additional 2 days are allowed in the event of logistical issues for receiving the results on time).
  • Participants known to be or having been infected with human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV), and require anti-viral therapy or prophylaxis. Note: Serology testing is mandatory for patients with unknown status.
  • History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
  • Failure to recover ≤ Grade 1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (except ≤ Grade 2 neuropathy or alopecia), due to previous therapy, prior to screening.
  • Hodgkin lymphoma (HL) with central nervous system involvement, including leptomeningeal disease.
  • Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
  • Breastfeeding or pregnant.
  • Significant medical comorbidities, including uncontrolled hypertension (blood pressure [BP] ≥ 160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 3 months prior to screening, severe uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease.
  • Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug, except shorter if approved by the Sponsor.
  • Use of any other experimental medication within 30 days prior to start of study drug.
  • Any live vaccine within 4 weeks prior to start of study drug and planned live vaccine administration after starting study drug.
  • Congenital long QT (measure between Q wave and T wave in the electrocardiogram) syndrome, or a corrected QTc interval of ≥ 480 ms, at screening (unless secondary to pacemaker or bundle branch block).
  • Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participants inappropriate for study participation or put the participant at risk.

Trial locations and contacts

73 sites in 11 countries.

73 sites in 11 countries

United States24 sites

  • Northside Hospital - Atlanta

    Atlanta, Georgia, 30342

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic - Taussig Cancer Center

    Cleveland, Ohio, 44195

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 40207

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Norton Cancer Institute - Saint Matthews

    Louisville, Kentucky, 40207

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center - New York

    New York, New York, 10065

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • UCSF Health - Hematology and Blood and Marrow Transplant Clinic

    San Francisco, California, 94143

  • Mayo Clinic - Arizona

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine in Saint Louis

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794-9452

Other trials in United States

Spain14 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    Barcelona, 08908

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Universitario Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca, 37007

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

France8 sites

  • Hôpitaux Universitaires Henri Mondor

    Créteil, 94000

  • Hôpital François Mitterrand

    Dijon, 21000

  • Clinique Victor Hugo Le Mans

    Le Mans, 72000

  • Hôpital Saint-Eloi

    Montpellier, 34295

  • Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

    Rouen, 76038

Other trials in France

United Kingdom6 sites

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH

Other trials in United Kingdom

Belgium5 sites

  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

    Bruges, 8000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi - Notre Dame

    Charleroi, 6000

  • Hôpital de Jolimont

    La Louvière

  • Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

    Yvoir, B-5530

Other trials in Belgium

Italy5 sites

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria

    Alessandria, 15121

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

    Bologna, 40138

  • Istituto Clinico Humanitas

    Milan, 20089

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80100

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128

Other trials in Italy

Canada3 sites

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, V5Z 4E6

  • British Columbia Cancer Agency

    Vancouver, British Columbia, BC V5Z 4E6

Other trials in Canada

Czechia3 sites

  • Fakultní Nemocnice Brno

    Brno, 625 00

  • Fakultní Nemocnice Královské Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Hungary2 sites

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Pécsi Tudományegyetem

    Pécs, 7624

Other trials in Hungary

Poland2 sites

  • Szpital Wojewódzki w Opolu

    Opole, 45-061

  • Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

    Wroclaw

Other trials in Poland

Germany1 site

  • Universitätsklinikum Halle

    Halle, 06120

Other trials in Germany

About this study

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

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).

Read the detailed description

This is a phase 2, multi-center, 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.

Being tested
Camidanlumab Tesirine
Keywords
Camidanlumab Tesirine; Relapsed or Refractory Hodgkins Lymphoma; Classical Hodgkins Lymphoma; Lymphoma
Medical subject headings
Hodgkin Disease, Recurrence, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camidanlumab TesirineDrug

    Also called ADCT-301

    Intravenous Infusion

Study groups in NCT04052997
Study groupRoleWhat they receive
Camidanlumab TesirineExperimentalCamidanlumab Tesirine is administered as a 30- minute intravenous (IV) infusion on Day 1 of each cycle (every 3 weeks). Camidanlumab Tesirine will be administered at a dose of 45 μg/kg every 3 weeks for 2 cycles, then 30 μg/kg for subsequent cycles.
Receives: Drug: Camidanlumab Tesirine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Data from the All-treated Population.

    Measured: Up to 3 years

Secondary outcomes (39)

  1. Duration of Response (DOR)

    DOR defined as the time from the first documentation of tumor response to disease progression or death.

    Measured: Up to 3 years

  2. CR Rate

    CR rate defined as the number of treated participants with a best overall response (BOR) of CR.

    Measured: Up to 3 years

  3. Relapse-Free Survival (RFS)

    RFS defined as the time from the documentation of CR to disease progression or death.

    Measured: Up to 3 years

  4. Progression-Free Survival (PFS)

    PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.

    Measured: Up to 3 years

  5. Overall Survival (OS)

    OS defined as the time from first dose of study drug until death due to any cause.

    Measured: Up to 3 years

  6. Number of Participants Who Received Hematopoietic Stem Cell Transplant (HSCT)

    Participants receiving HSCT following camidanlumab tesirine, and without any other anticancer therapy in between, other than the therapies preparing for HSCT, were included in this analysis.

    Measured: Up to 3 years

  7. Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs.

    Measured: Up to 3 years

  8. Number of Participants Who Experienced At Least One Serious Adverse Event (SAE)

    An SAE is defined as any adverse event (AE) that:

    • results in death.
    • is life threatening.
    • requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE).
    • results in persistent or significant disability/incapacity.
    • is a congenital anomaly/birth defect.
    • important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs.

    Measured: Up to 3 years

  9. Number of Participants With ECOG Performance Status Score of 0-3 at the End of Trial (EOT)

    The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.

    Measured: EOT (up to 3 years)

  10. Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  11. Cmax of Camidanlumab Tesirine Unconjugated Warhead SG3199

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  12. Cmax of Camidanlumab Tesirine PBD-Conjugated Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  13. Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody

    Measured: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  14. AUCtau For Camidanlumab Tesirine PBD-Conjugated Antibody

    Measured: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  15. AUCtau For Camidanlumab Tesirine Unconjugated Warhead SG3199

    No data collected for this endpoint.

    Measured: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  16. Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  17. AUClast For Camidanlumab Tesirine PBD-Conjugated Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  18. AUClast For Camidanlumab Tesirine Unconjugated Warhead SG3199

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  19. Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  20. AUCinf For Camidanlumab Tesirine PBD-Conjugated Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  21. AUCinf For Camidanlumab Tesirine Unconjugated Warhead SG3199

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  22. Clearance (CL) For Camidanlumab Tesirine Total Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  23. CL For Camidanlumab Tesirine PBD-Conjugated Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  24. CL For Camidanlumab Tesirine Unconjugated Warhead SG3199

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  25. Clearance at Steady State (CLss) For Camidanlumab Tesirine Total Antibody

    Measured: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  26. CLss For Camidanlumab Tesirine PBD-Conjugated Antibody

    Measured: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  27. CLss For Camidanlumab Tesirine Unconjugated Warhead SG3199

    Measured: Cycle 2 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  28. Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  29. T1/2 For Camidanlumab Tesirine PBD-Conjugated Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  30. T1/2 For Camidanlumab Tesirine Unconjugated Warhead SG3199

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  31. Volume of Distribution at Steady State (Vss) For Camidanlumab Tesirine Total Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  32. Vss For Camidanlumab Tesirine PBD-Conjugated Antibody

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  33. Vss For Camidanlumab Tesirine Unconjugated Warhead SG3199

    Measured: Cycle 1 (one cycle = 21 days): day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h). Cycle 2: day 1 (predose, EOI, 4h postdose), day 8 (168h), day 15 (336h)

  34. Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody

    AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

    Measured: Cycle 1 and 2: day 0 to 21

  35. AI For Camidanlumab Tesirine PBD-Conjugated Antibody

    AI is the ratio of AUC from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

    Measured: Cycle 1 and 2: day 0 to 21

  36. AI For Camidanlumab Tesirine Unconjugated Warhead SG3199

    AI is the ratio of AUC from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

    Measured: Cycle 1 and 2: day 0 to 21

  37. Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Post Dose

    Detection of ADAs was performed by using a screening assay for identification of antibody positive samples/participants, a confirmation assay, and titer assessment.

    Measured: Up to 3 years

  38. Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)

    Participants were asked to indicate their health state on a VAS with scores ranging from 'the worst health you can imagine' (score 0) to 'the best health you can imagine' (score 100). Participants are asked to mark an "X" on the VAS to indicate their own health and then to report the score in a text box. Positive changes from Baseline represent an an improvement in heath.

    Measured: Baseline, Day 1 of Cycles 2 to 15 (one cycle = 21 days) and EOT (up to 3 years)

  39. Change From Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

    The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.

    Measured: Baseline, Day 1 of Cycles 2 to 15 (one cycle = 21 days) and EOT (up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2019
  2. Study start13 Sep 2019
  3. Primary completion19 Jan 2023
  4. Study completion19 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04052997
Sponsor's protocol ID
ADCT-301-201
Other IDs
2018-002556-32, 2018
Status last verified
Mar 2024
First submitted
7 Aug 2019
Last updated
28 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Herrera AF, Ansell SM, Zinzani PL, Radford J, Maddocks K, Pinto A, Collins GP, Bachanova V, Bartlett NL, Bence-Bruckler I, Hamadani M, Kline J, Mayer J, Savage KJ, Advani RH, Caimi PF, Casasnovas RO, Feldman T, Hess B, Bastos-Oreiro M, Iyengar S, Szomor A, Townsend W, Andre M, Dyczkowski J, Havenith K, Toukam M, Pantano S, Cruz HG, Wang L, Negievich Y, Lucero M, Wuerthner J, Carlo-Stella C. Camidanlumab tesirine for relapsed or refractory classic Hodgkin lymphoma: a phase 2 study. Blood Adv. 2025 Dec 9;9(23):6205-6217. doi: 10.1182/bloodadvances.2024015600.

    PubMed 40811783

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camidanlumab Tesirine in people with Relapsed Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, run by ADC Therapeutics S.A. at 73 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Spain, France, United Kingdom, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04052997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

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