Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.

Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.

A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).

Camidanlumab tesirine

Jens Wuerthner, MD, PhD

This study evaluates camidanlumab tesirine in participants with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma.

This is a Phase I, first in human clinical study with camidanlumab tesirine to evaluate the safety and tolerability and pharmacokinetics of camidanlumab tesirine in participants with relapsed/refractory lymphoma.

Camidanlumab tesirine is a human monoclonal antibody attached via a cleavable linker to a pyrrolobenzodiazepine (PBD) warhead which, when internalized by antigen expressing cells, covalently cross links deoxyribonucleic acid (DNA) preventing replication.

The study will be conducted in 2 parts: Part 1 (dose escalation) and Part 2 (expansion).

Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma

A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients With Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma

A DLT defined as any of the following, except those that are clearly due to underlying disease or extraneous causes:

A hematologic DLT is defined as (different considerations for Adult T-Cell Leukemia/Lymphoma (ATLL) participants):

* Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 febrile neutropenia or neutropenic infection
* CTCAE Grade 4 neutropenia lasting \>7 days
* CTCAE Grade 4 thrombocytopenia
* CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion
* CTCAE Grade 4 anemia

A non-hematologic DLT is defined as:

* CTCAE Grade 4 tumor lysis syndrome
* CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, electrolyte imbalances lasting ≥ 48 hours despite optimal therapy; excluding all grades of alopecia)
* CTCAE Grade 3 or higher hypersensitivity reaction
* CTCAE Grade 2 or higher skin ulceration
* CTCAE Grade 2 or higher peripheral sensory or motor neuropathy

The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.

An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.

A treatment-emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

ORR is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with camidanlumab tesirine.

Tumor response was assessed using the 2014 Lugano Classification.

CR is defined as achieving each of the following:

* Complete metabolic response.
* Complete radiologic response (target node regress to \<1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).

PR is defined as achieving each of the following:

* Partial metabolic response (findings indicate residual disease).
* Partial remission (\>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by \>50% in length and no new lesions).

DoR is defined among responders (complete response \[CR\] and partial response \[PR\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification.

Disease progression is defined as progressive metabolic disease and one of the follow:

* Target node progression.
* An individual extranodal lesion must be abnormal with length \> 1.5cm and/or increase of length \> 50%.
* New or clear progression of nonmeasured lesions.
* Regrowth of previously resolved lesions or new nodes \>1.5 cm in length.
* New or recurrent bone marrow involvement.

DoR is presented overall for all participants who were classed as responders among the efficacy analysis set. Data is pooled for all lymphoma participants for DoR as specified in protocol section 8.4.

Progression-free survival (PFS) is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.

Disease progression is defined as progressive metabolic disease and one of the following:

* Target node progression.
* An individual extranodal lesion must be abnormal with length \> 1.5cm and/or increase of length \> 50%.
* New or clear progression of nonmeasured lesions.
* Regrowth of previously resolved lesions or new nodes \> 1.5 cm in length.
* New or recurrent bone marrow involvement.

PFS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for PFS as specified in protocol section 8.4

Overall survival (OS) is defined as the time from the first dose of study drug treatment until the date of death due to any cause.

OS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for OS as specified in protocol section 8.4.

Cmax for HuMax-TAC, pyrrolobenzodiazepine (PBD) conjugated HuMax-TAC, and free warhead (SG3199).

Tmax for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

AUC0-last for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

AUC0-tau for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199) for Cycle 2 only.

AUC∞ HuMax-TAC and PBD-conjugated HuMax-TAC for Cycle 1 only.

AI for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199). 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 (21 day cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.

Volume of distribution for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

T1/2 of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

Clearance of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).

An assay determines the presence of anti-ADCT-301 antibodies in human serum using a validated bridging electro chemiluminescence immunoassay (ECLIA) technique. The technique uses the drug itself to capture any anti ADCT-301 antibodies present in the serum. If anti-ADCT-301 antibodies are detected, they are confirmed to be specifically against ADCT-301 and then the level of the anti-ADCT-301 antibodies present in the serum is established using a modified version of the ECLIA technique.

ADC Therapeutics S.A.

AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).

Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

3 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

5 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

8 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

13 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

20 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

30 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

45 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

60 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

80 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

100 μg/kg

Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.

Camidanlumab tesirine: Intravenous (IV) infusion.

150 μg/kg

A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).

Camidanlumab tesirine: Intravenous (IV) infusion.

300 μg/kg

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

United Kingdom

Region of Enrollment

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

ECOG performance status was graded on a scale of 0-5, where a higher score indicated a worse outcome:

0. = fully active

1. = capable of light work of a sedentary nature
2. = capable of self-care; unable to carry out work activities
3. = capable of only limited self-care
4. = completely disabled; cannot carry out any self-care
5. = dead

Eastern Cooperative Oncology Group (ECOG) Performance Status

Weight

One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.

Height

One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.

Body Mass Index

Clinical Trials Information

DLT Evaluable Analysis Set: The DLT-evaluable analysis set consisted of participants who completed two cycles of ADCT-301 if enrolled prior to protocol amendment 4 and participants who completed one cycle of ADCT-301 if enrolled after protocol amendment 4. The participants with completed DLT information were included even if they discontinued early before the end of cycle 2 or cycle 1 respectively.

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Participants with Hodgkin Lymphoma (Dose level 1: 30 µg/kg)

Participants with Hodgkin Lymphoma (Dose level 2: 45 µg/kg)

Participants with T-cell Lymphoma (80 µg/kg)

Dose-Limiting Toxicity (DLT) Evaluable Set Analysis Set

Number of participants analyzed presented in the outcome measure data are only those participants in the DLT evaluable analysis set who were dosed at the three dose levels recommended for Part 2.

Recommended Dose of Camidanlumab Tesirine for Part 2

Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)

Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)

Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.

Overall Response Rate (ORR)

Participants received an intravenous (IV) infusion of camidanlumab tesirine at any dose (doses ranging from 3 μg/kg to 300 μg/kg) on Day 1 of each 3-week treatment cycle. The maximum number of cycles received was 15.

Efficacy Analysis Set

Duration of Response (DoR)

Progression-Free Survival (PFS)

Overall Survival (OS)

Cycle 1 - HuMax-TAC

Cycle 2 - HuMax-TAC

Cycle 1 - PBD-conjugated HuMax-TAC

Cycle 2 - PBD-conjugated HuMax-TAC

Cycle 1 - Free warhead (SG3199)

Cycle 2 - Free warhead (SG3199)

Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.

Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine

Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine

Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine

Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine

Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine

HuMax-TAC

PBD-conjugated HuMax-TAC

Free warhead (SG3199)

Accumulation Index (AI) for Camidanlumab Tesirine

Volume of Distribution for Camidanlumab Tesirine

Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine

Clearance of Camidanlumab Tesirine

Confirmed positive ADA pre-dose

Confirmed positive ADA post-dose only

Confirmed positive ADA at any time

Safety Analysis Set - The safety analysis set consisted of all participants who received camidanlumab tesirine.

Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine

Overall Study

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Weekly administration - Participants will receive an IV infusion of ADCT-301, on Days 1, 8, and 15 of each 3-week (21-day) cycle.

3-week administration - Participants will receive an IV infusion of ADCT-301, on Day 1 of each 3-week (21-day) cycle.

The dose escalation will be conducted according to a 3+3 design.

Participants will be assigned to receive the recommended dose and/or schedule of ADCT-301 as determined by the Dose Escalation Steering Committee.

ADCT-301

Aaron Goldberg, MD

This study evaluates ADCT-301 in participants with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL). Participants will participate in a dose-escalation phase (Part 1) and receive ADCT-301 either weekly or once every 3 weeks.

In Part 2 of the study, participants will receive a recommended dose of ADCT-301 as determined by a Dose Escalation Steering Committee.

This is a Phase 1 study with ADCT-301 to evaluate the safety, tolerability and pharmacokinetics of ADCT-301 in participants with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL).

ADCT-301 is a human monoclonal antibody attached via a cleavable linker to a pyrrolobenzodiazepine (PBD) warhead which, when internalized by antigen expressing cells, covalently cross links deoxyribonucleic acid (DNA) preventing replication.

The study will be conducted in 2 parts: In Part 1 (dose escalation) participants will either be on weekly administration or every 3-week administration. Participants on weekly administration will receive an infusion of ADCT-301 on Days 1, 8, and 15 of each 3 week treatment cycle. Participants on 3-week administration will receive an infusion of ADCT-301 on Day 1, every 3 weeks. Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

In Part 2 (expansion), participants will be assigned to receive a recommended dose and/or schedule of ADCT-301 as determined by a Dose Escalation Steering Committee.

For each participant, the study will include a screening period (up to 28 days), a treatment period, and a follow-up period to assess disease progression and survival for up to 12 months after the last dose of study drug. The total study duration will be dependent on overall participant tolerability to the study drug and response to treatment. It is anticipated that the entire study (Parts 1 and 2) will enroll a maximum of 80 participants and could last approximately 3 years from first participant treated to last participant completed.

Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL)

A Phase 1, Open-label, Dose-escalation, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Activity of ADCT 301 in Patients With Relapsed or Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia

A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes:

A hematologic DLT is defined as:

- Grade 3 or higher event of neutropenia or thrombocytopenia, or a Grade 4 anemia, with a hypocellular bone marrow lasting for 6 weeks or more after the start of a cycle, in the absence of residual leukemia (i.e., with \<5% blasts). In case of a normocellular bone marrow with \<5% blasts, 8 weeks with ≥Grade 3 pancytopenia will be considered a DLT.

A non-hematologic DLT is defined as:

* Grade 4 tumor lysis syndrome.
* Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia).
* CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication).
* CTCAE Grade 3 or higher skin ulceration.
* Peripheral sensory or motor neuropathy ≥ Grade 2.

The recommended dose was to be established by the dose escalation steering committee and based on safety findings during part 1 of the study.

A TEAE is defined as any adverse event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.

An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Hospitalization for elective procedures or for protocol compliance is not considered an SAE.

DOR is defined among responders (complete response \[CR\], CR with incomplete blood count recover \[CRi\], or partial response \[PR\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders.

CR:

* Bone marrow differential showing ≤5% blast cells.
* Absolute neutrophil count (ANC) ≥1.0 x 10\^9/L and platelet count ≥100 x 10\^9/L.
* Absence of extramedullary disease.
* Participant is independent of red blood cell transfusions.

CRi is defined as achieving all CR criteria except that values for ANC may be \<1.0 x 10\^9/L and/or values for platelets may be \<100 x 10\^9/L.

PR:

* ANC ≥1.0 x 10\^9/L and platelet count ≥100 x 10\^9/L.
* Bone marrow differential showing a ≥50% decrease from baseline in the percentage of bone marrow blast cells to a level \>5% and ≤25%, or bone marrow differential showing \<5% blast cells.

ORR is defined as the percentage of participants with a best overall response of CR, CRi, or PR at the time each participant discontinues treatment with ADCT-301. A summary of antitumor activity was not conducted due to a limited number of responders.

OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders.

PFS is defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders.

Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohorts.

Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. 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.

AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 7 days divided by AUC from 7 to 14 days for Cycle 1.

Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.

CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.

Blood serum samples were collected and analysed to determine the presence or absence of ADA. Results were pooled for Part 1 participants as specified in the protocol.

Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).

Cohort 1: 3 μg/kg Q3W

Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).

Cohort 2: 6 μg/kg Q3W

Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).

Cohort 3: 12 μg/kg Q3W

Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).

Cohort 4: 22 μg/kg Q3W

Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma	NCT02432235	Hodgkin Lymphom... Non-Hodgkin Lym...	Camidanlumab te...	18 Years -	ADC Therapeutics S.A.
Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL)	NCT02588092	Acute Myeloid L... Acute Lymphobla...	ADCT-301	18 Years -	ADC Therapeutics S.A.
Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma	NCT02432235	Hodgkin Lymphom... Non-Hodgkin Lym...	Camidanlumab te...	18 Years -	ADC Therapeutics S.A.
Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL)	NCT02588092	Acute Myeloid L... Acute Lymphobla...	ADCT-301	18 Years -	ADC Therapeutics S.A.
Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma	NCT04052997	Relapsed Hodgki... Refractory Hodg...	Camidanlumab Te...	16 Years -	ADC Therapeutics S.A.
Study of ADCT-301 in Patients With Selected Advanced Solid Tumors	NCT03621982	Advanced Solid ... Head and Neck C... Non-small Cell ... Gastric Cancer Esophageal Canc... Pancreas Cancer Bladder Cancer Renal Cell Carc... Melanoma Triple-negative... Ovarian Cancer Colo-rectal Can... Fallopian Tube ...	ADCT-301 Pembrolizumab	18 Years -	ADC Therapeutics S.A.

Spots Global Cancer Trial Database for camidanlumab tesirine