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Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03621982
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
ADC Therapeutics S.A.

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE November 9, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Assessment of Dose Limiting Toxicities in Determination of the Maximum Tolerated Dose Dose Limiting toxicities as defined per protocol, as related to ADCT-301 [ Time Frame: Up to 3 years ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a casual relationship with this treatment.
  • Number of Adverse Events of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above [ Time Frame: Up to 3 years ]
    Adverse events will be graded according to CTAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.
  • Number of Serious Adverse Events (SAE) [ Time Frame: Up to 3 years ]
    A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of 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 or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.
  • Number of SAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above [ Time Frame: Up to 3 years ]
    AEs will be graded according to CTCAE v.4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.
  • Number of Dose Interruptions and/or Dose Reductions [ Time Frame: Up to 3 years ]
  • Number of Dose Limiting Toxicities [ Time Frame: Up to 3 years ]
  • Number of Participants who Experience a Clinically Significant Change in Baseline in Laboratory Values [ Time Frame: Up to 3 years ]
  • Number of Participants who Experience a Clinically Significant Change in Baseline in Vital Signs [ Time Frame: Up to 3 years ]
  • Number of Participants who Experience a Clinically Significant Change in Baseline in Electrocardiogram (ECG) Results [ Time Frame: Up to 3 years ]
  • Number of Particpants who Experience a Clinically Significant Change in Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Up to 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
Assessment of Dose Limiting Toxicities in Determination of the Maximum Tolerated Dose Dose Limiting toxicities as defined per protocol, as related to ADCT-301 [ Time Frame: The protocol-defined assessment period is one 21-day cycle ]
Change History Complete list of historical versions of study NCT03621982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • Evaluate the preliminary anti-tumor activity of camidanlumab tesirine [ Time Frame: Disease assessments will occur 6 weeks and 12 weeks after Cycle 1 Day 1, then every 12 weeks (cycle = 21 days) ]
    Overall response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and iRECIST
  • Evaluate the preliminary anti-tumor activity of camidanlumab tesirine [ Time Frame: Disease assessments will occur 6 weeks and 12 weeks after Cycle 1 Day 1, then every 12 weeks (cycle = 21 days) ]
    Duration of response (DOR) defined as the time from the first documentation of tumor response to disease progression or death
  • Evaluate the preliminary anti-tumor activity of camidanlumab tesirine [ Time Frame: Disease assessments will occur 6 weeks and 12 weeks after Cycle 1 Day 1, then every 12 weeks (cycle = 21 days) ]
    Progression-free survival (PFS) defined as the time between start of treatment and the first documentation of recurrence, progression, or death
  • Evaluate the preliminary anti-tumor activity of camidanlumab tesirine [ Time Frame: Disease assessments will occur 6 weeks and 12 weeks after Cycle 1 Day 1, then every 12 weeks (cycle = 21 days) ]
    Overall survival (OS) defined as the time between the start of treatment and death from any cause
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8, and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every subsequent cycle (cycle=21 days) ]
    Noncompartmental analysis of the maximum concentration (Cmax)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8, and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every subsequent cycle (cycle=21 days) ]
    Noncompartmental analysis of the time to maximum concentration (Tmax)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8, and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every subsequent cycle (cycle=21 days) ]
    Noncompartmental analysis of the area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0 last)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8, and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every subsequent cycle (cycle=21 days) ]
    Noncompartmental analysis of the area under the concentration-time curve from time zero to infinity (AUC0-∞)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8, and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every subsequent cycle (cycle=21 days) ]
    Noncompartmental analysis of the area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-τ)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8, and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every subsequent cycle (cycle=21 days) ]
    Noncompartmental analysis of the accumulation index (AI)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8, and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every subsequent cycle (cycle=21 days) ]
    Noncompartmental analysis of clearance (CL)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8, and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every subsequent cycle (cycle=21 days) ]
    Noncompartmental analysis of volume of distribution (Vd)
  • Number of confirmed positive anti-drug antibody (ADA) responses [ Time Frame: Blood sample collection on Day 1 and Day 15 for Cycle 1 and Day 1 only for Cycle 2,Cycle 3,Cycle 4 and then Day 1 of every other cycle (cycle = 21 days) ]
    ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • Evaluate the preliminary anti-tumor activity of camidanlumab tesirine [ Time Frame: Disease assessments will occur 6 weeks and 12 weeks after Cycle 1 Day 1, then every 12 weeks (cycle = 21 days) ]
    Overall response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and iRECIST
  • Evaluate the preliminary anti-tumor activity of camidanlumab tesirine [ Time Frame: Disease assessments will occur 6 weeks and 12 weeks after Cycle 1 Day 1, then every 12 weeks (cycle = 21 days) ]
    Duration of response (DOR) defined as the time from the first documentation of tumor response to disease progression or death
  • Evaluate the preliminary anti-tumor activity of camidanlumab tesirine [ Time Frame: Disease assessments will occur 6 weeks and 12 weeks after Cycle 1 Day 1, then every 12 weeks (cycle = 21 days) ]
    Progression-free survival (PFS) defined as the time between start of treatment and the first documentation of recurrence, progression, or death
  • Evaluate the preliminary anti-tumor activity of camidanlumab tesirine [ Time Frame: Disease assessments will occur 6 weeks and 12 weeks after Cycle 1 Day 1, then every 12 weeks (cycle = 21 days) ]
    Overall survival (OS) defined as the time between the start of treatment and death from any cause
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8 and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every other subsequent cycle (cycle = 21 days) ]
    Noncompartmental analysis of the maximum concentration (Cmax)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8 and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every other subsequent cycle (cycle = 21 days) ]
    Noncompartmental analysis of the time to maximum concentration (Tmax)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8 and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every other subsequent cycle (cycle = 21 days) ]
    Noncompartmental analysis of the area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0 last)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8 and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every other subsequent cycle (cycle = 21 days) ]
    Noncompartmental analysis of the area under the concentration-time curve from time zero to infinity (AUC0-∞)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8 and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every other subsequent cycle (cycle = 21 days) ]
    Noncompartmental analysis of the area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-τ)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8 and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every other subsequent cycle (cycle = 21 days) ]
    Noncompartmental analysis of the accumulation index (AI)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8 and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every other subsequent cycle (cycle = 21 days) ]
    Noncompartmental analysis of clearance (CL)
  • Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum [ Time Frame: Blood sample collection on Day 1, 3, 5, 8 and 15 for Cycles 1 and 2; Day 1 for Cycles 3 and 4; Day 1 for every other subsequent cycle (cycle = 21 days) ]
    Noncompartmental analysis of volume of distribution (Vd)
  • Evaluate the immunogenicityof camidanlumab tesirine [ Time Frame: Blood sample collection on Day 1 and Day 15 for Cycle 1 and Day 1 only for Cycle 2,Cycle 3,Cycle 4 and then Day 1 of every other cycle (cycle = 21 days) ]
    Anti-drug antibody (ADA) titers in serum
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
Official Title  ICMJE A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) in Patients With Selected Advanced Solid Tumors
Brief Summary This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.
Detailed Description

This is a Phase 1b, multi-center, open-label study with a dose-escalation part and a dose expansion part.

The duration of the study participation for each patient is defined as the time from the date of signed written informed consent to the completion of the follow-up period, withdrawal of consent, loss to follow-up, or death, whichever occurs first.

The study will include a Screening Period (of up to 21 days), a Treatment Period (with cycles of 3 weeks for a Q3W dosing regimen), and a Follow-up Period (approximately every 12 week visits) for up to 1 year after treatment discontinuation

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors With Literature Evidence of CD25(+) Treg Content
  • Head and Neck Cancer
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Pancreas Cancer
  • Bladder Cancer
  • Renal Cell Carcinoma
  • Melanoma
  • Triple-negative Breast Cancer
  • Ovarian Cancer
  • Colo-rectal Cancer
Intervention  ICMJE Drug: ADCT-301
intravenous infusion
Other Name: Camidanlumab tesirine
Study Arms  ICMJE Experimental: ADCT-301

In Part 1 (dose-escalation), patients will receive a 1-hour intravenous infusion of ADCT-301 on Day 1 every 3 weeks (21-day cycle) at escalating doses. Part 1 will continue until the maximum tolerated dose or the recommended dose(s) and schedule(s) for expansion are determined.

In Part 2 (expansion), patients will be assigned to receive the recommended dose(s) of ADCT-301 as determined by the Dose Escalation Steering Committee (DESC).

This study will investigate dose levels between 20 μg/kg and 300 μg/kg Q3W.

Intervention: Drug: ADCT-301
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
62
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2018)
50
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent must be obtained prior to any procedures.
  2. Male or female patient aged 18 years or older.
  3. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of Screening:

    Part 1 (Dose-Escalation):

    Selected advanced solid tumors: colorectal, head and neck, NSCLC, gastric and esophageal cancers, pancreas, bladder, renal cell carcinoma, melanoma, TNBC, and ovarian cancers

    Part 2 (Dose-Expansion):

    • Group 1: One of the indications identified in Part 1, for which at least 1 response (PR or CR) was seen.
    • Group 2: Any indication allowed in Part 1, except for the one selected for Group 1.
  4. Patients who are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
  5. Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST v1.1 or irRC/irRECIST/iRECIST.
  6. Patient must have a site of disease amenable to biopsy and be willing to undergo fresh biopsy procedures (minimum 3 passes each) prior to first dose, according to the treating institution's guidelines.

    Patients included in the paired-biopsy cohort must in addition be willing to undergo fresh biopsy procedures (minimum 3 passes each) after receiving at least one dose of study drug.

  7. ECOG performance status 0-1.
  8. Adequate organ function as defined by screening laboratory values within the following parameters:

    1. Absolute neutrophil count (ANC) ≥ 1.5 × 10^3/μL (off growth factors at least 72 h).
    2. Platelet count ≥100 × 10^3/μL without transfusion in the past 10 days.
    3. Hemoglobin ≥9 g/dL (5.6 mmol/L) (prior transfusion allowed).
    4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyl transferase (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.
    5. Total bilirubin ≤1.5 × ULN (patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN with direct bilirubin ≤1.5 × ULN).
    6. Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the Cockcroft-Gault equation.
  9. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
  10. Women of childbearing potential* must agree to use a highly effective** method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of camidanlumab tesirine. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of camidanlumab tesirine.

Exclusion Criteria:

  1. Participation in another investigational interventional study.
  2. Prior therapy with a CD25 (IL-2R) antibody within the last 4 months.
  3. Known history of ≥Grade 3 hypersensitivity to a therapeutic antibody.
  4. Patients with prior solid organ or allogeneic bone marrow transplant.
  5. 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 I diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
  6. History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
  7. History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the following pathogens: herpes simplex virus 1/2 (HSV1, HSV2), varicella zoster (VZV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.
  8. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). Note: Testing is not mandatory to be eligible but should be considered in patients with high risk for these infections.
  9. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
  10. Failure to recover to ≤Grade 1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute nonhematologic toxicity (to ≤Grade 2 for neuropathy or alopecia), due to previous therapy, prior to screening.
  11. Symptomatic CNS metastases or evidence of leptomeningeal disease (brain MRI or previously documented cerebrospinal fluid [CSF] cytology). Previously treated asymptomatic CNS metastases are permitted provided that the last treatment (systemic anticancer therapy and/or local radiotherapy) was completed ≥8 weeks prior to Day 1 except usage of low dose of steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and consecutive days is permissible if being tapered down). Patients with discrete dural metastases are eligible.
  12. 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).
  13. Active diarrhea CTCAE Grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease).
  14. Active infection requiring systemic antibiotic therapy.
  15. Active bleeding diathesis or significant anticoagulation (international normalized ratio [INR] ≥2.0).
  16. Breastfeeding or pregnant.
  17. Significant medical comorbidities, including uncontrolled hypertension (blood pressure [BP] ≥160 mmHg systolic and/or ≥110 mmHg diastolic repeatedly with or without anti hypertensive medication), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, severe uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, active ulceration of the upper gastrointestinal (GI) tract or GI bleeding, or severe chronic pulmonary disease.
  18. Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor. For cytotoxic agents that have major delayed toxicity, e.g., mitomycin C and nitrosoureas, 4 weeks is indicated as washout period. For patients receiving systemic anticancer immunotherapies (as opposed to intralesional) that lead to activation of Teffs and/or increase the Teff/Treg ratio, such as anti-PD-1 antibodies, 4 weeks are indicated as the washout period.
  19. Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
  20. Patients requiring concomitant immunosuppressive agents or chronic treatment with corticosteroids except:

    • replacement dose steroids in the setting of adrenal insufficiency
    • topical, inhaled, nasal, and ophthalmic steroids are allowed
  21. Planned live vaccine administration after starting study drug (C1D1).
  22. Congenital long QT syndrome, or a corrected QTcF interval of ≥ 480 ms, at screening (unless secondary to pacemaker or bundle branch block).
  23. 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.
  24. Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ADC Therapeutics 954-903-7994 clinical.trials@adctherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03621982
Other Study ID Numbers  ICMJE ADCT-301-103
2019-003132-23 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ADC Therapeutics S.A.
Study Sponsor  ICMJE ADC Therapeutics S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ADC Therapeutics S.A.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP