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

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) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03621982

Enrollment

Registered

2018-08-09

Start date

2018-11-09

Completion date

2022-12-14

Last updated

2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Colo-rectal Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer, Head and Neck Cancer Squamous Cell Carcinoma, Melanoma, Non-small Cell Lung Cancer, Ovarian Cancer, Pancreas Cancer, Renal Cell Carcinoma, Triple-negative Breast Cancer

Keywords

Camidanlumab tesirine

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 participant was defined as the time from the date of signed written informed consent to the completion of the followup period, withdrawal of consent, loss to follow-up, or death, whichever occurs first. The study was 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.

Interventions

DRUGADCT-301

intravenous infusion

BIOLOGICALPembrolizumab

intravenous infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Written informed consent must be obtained prior to any procedures. 2. Male or female participants 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 camidanlumab tesirine as monotherapy: Selected advanced solid tumors: colorectal, head and neck, NSCLC, gastric and esophageal cancers, pancreas, bladder, renal cell carcinoma, melanoma, TNBC, and ovarian/fallopian tube cancers Part 1 Dose-escalation camidanlumab tesirine in combination with pembrolizumab: Selected advanced solid tumors: colorectal cancer, gastric-esophageal cancer, ovarian /fallopian tube cancer, pancreatic cancer, non-small cell lung cancer, and melanoma. Note: For colorectal cancer, gastric-esophageal cancer, ovarian/fallopian tube cancer, pancreatic cancers mismatch repair (MMR) / microsatellite stability (MSS) / microsatellite instability (MSI) status was mandatory. If MMR/MSS/MSI status was not available at signature of the informed consent, the test should be performed before Cycle 1 Day 1 (C1D1). Part 2 Dose expansion camidanlumab tesirine in combination with pembrolizumab: * Group 1: One of the indications identified in Part 1, for which at least 1 response (PR or CR) was seen. * Group 2: Participants with advanced solid tumors and MSI-H/dMMR status, who had received a prior regimen containing PD-1/PD-L1 inhibitors, for which the best response was CR, PR, or SD ≥4 months, and then progressed while under treatment with the PD-1/PD-L1 inhibitor-based regimen. Note: A maximum of 4 participants with the same indication was allowed in this basket group. 4. Participants who were refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. 5. Participants with advanced/metastatic cancer, with measurable disease as determined by RECIST v1.1 or immune-related Response Criteria (irRC)/ immune-related Response Evaluation Criteria In Solid Tumors (irRECIST)/ immune-related Response Evaluation Criteria In Solid Tumors (iRECIST)/ immune-modified Response Evaluation Criteria in Solid Tumors (imRECIST) as per Investigator discretion. 6. A) For camidanlumab tesirine as monotherapy: Participant must have a site of disease amenable to biopsy and was willing to undergo fresh biopsy procedures (minimum 3 passes each) prior to first dose, according to the treating institution's guidelines. B) Participants included in the paired-biopsy cohort must in addition be willing to undergo fresh biopsy procedures (minimum 3 passes each) after receiving at least 1 dose of study drug. C) For camidanlumab tesirine in combination with pembrolizumab: Participant must either had a site of disease amenable to biopsy and must provide fresh tumor biopsy prior to C1D1, or have sufficient available archival tumor tissue (biopsied after their last disease progression, and in the situation where the participant had received no additional anti-cancer therapy between their progression and C1D1). Participants were must willing to undergo fresh biopsy procedures (minimum 3 passes each) after receiving at least 1 dose of study treatment, according to the treating institution's guidelines. 7. ECOG performance status 0-1. 8. Participant with life expectancy ≥ 3 months as per Investigator assessment. 9. 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 hours). 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. 10. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential (WOCBP). 11. Women of childbearing potential 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 or 4 months after last dose of pembrolizumab, whichever is the latest. Men with female partners who were 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 6.5 months after the participant received the last dose of camidanlumab tesirine or 4 months after last dose of pembrolizumab, whichever was the latest.

Exclusion criteria

1. Participation in another investigational interventional study. 2. Prior therapy with a CD25 (IL-2R) antibody. 3. Known history of ≥Grade 3 hypersensitivity to a therapeutic antibody. 4. Participants 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 \[e.g., Wegener's granulomatosis\]) (participants with vitiligo, type 1 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) caused by a pathogen known to be associated with GBS, for example: herpes simplex virus 1/2 (HSV1, HSV2), varicella zoster virus (VZV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, enterovirus D68, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Note: An influenza test and a pathogen-directed SARS-CoV-2 test (such as polymerase chain reaction \[PCR\]) were 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 were allowed in the event of logistical issues for receiving the results on time). 8. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). Note: Testing was not mandatory to be eligible but should be considered in participants with high risk for these infections; testing was mandatory if status was unknown. 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 \[CTCAE version 4.0\]) 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 were permitted provided that the last treatment (systemic anticancer therapy and/or local radiotherapy) was completed ≥4 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 were permissible if being tapered down). Participants 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 participants received 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 were indicated as the washout period. 19. Use of any other experimental medication within 14 days prior to start of study drug (C1D1). 20. Participants 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 within 30 days prior to the first dose of study treatment and during study treatment. 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, made the participant inappropriate for study participation or put the participant at risk. 25. For participants treated with camidanlumab tesirine in combination with pembrolizumab: patients intolerant to checkpoint-inhibitor or with a history of the following ≥ Grade 3 immune-related adverse events: hepatitis, renal, ocular, neurologic, cardiovascular, rheumatologic, and hematologic. 26. For participants treated with camidanlumab tesirine in combination with pembrolizumab: participants with a history of non-infectious pneumonitis related to prior systemic treatment and that require treatment with steroids within the last 6 months prior to enrollment.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	Up to 3 years	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant 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, whichever is earlier. Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Up to 3 years	AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms, 2 is moderate, 3 is severe, 4 is Life-threatening consequences and 5 is death related to an AE.
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	Up to 3 years	A SAE is defined as any 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 or 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.
Number of Participants Who Experienced a SAE by CTCAE Grade	Up to 3 years	AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 is mild or asymptomatic, 2 is moderate, 3 is severe, 4 is Life-threatening and 5 is death related to an AE.
Number of Participants Who Experienced a Dose Interruption	Up to 3 years	Dose interruption for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Number of Participants Who Experienced a Dose Reduction	Up to 3 years	Dose reductions for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	Day 1 to Day 21	For the dose-escalation of ADCT-301 as monotherapy, DLT is defined as any of the following events like hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes. For the dose-escalation of ADCT-301 in combination with pembrolizumab, a DLT is defined as any of the following events ike hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes.

Secondary

Measure	Time frame	Description
Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose	The PK profile included AUCtau ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose	The PK profile included AI of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. AI is the ratio of accumulation of a drug under steady state conditions (i.e., after repeated administration) as compared to a single dose. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose	The PK profile included the CL of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	Up to 3 years	The ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The overall response category was derived based on response assessment performed on or before the start of subsequent anti-cancer therapy.
Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose	The PK profile included determination of Cmax in serum Total antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Number of Participants With Anti-drug Antibody (ADA) Response in Serum	C1D1, from Pre-dose to 336 hr post dose.	ADA testing included number of participants with positive pre-dose ADA response, number of participants with post-dose ADA response only, and number of participants with positive ADA response at any time. Collection of ADA was stopped if ADCT-301 administration was discontinued. For participants treated with ADCT-301 in combination with pembrolizumab, unless there was a penultimate observation of positive ADA response, no other collection of ADA data was necessary if ADCT-301 administration was discontinued. Upon consultation with the Sponsor, ADA samples were not collected anymore if ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose	The PK profile included the Thalf of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Duration of Response (DOR) as Per RECIST v 1.1	Up to 3 years	DOR is defined among objective responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression (based on radiographic or clinical progression at end of treatment \[EOT\]/end of study \[EOS\]) or death due to any cause.
Progression-free Survival (PFS) as Per RECIST v 1.1	Up to 3 years	PFS defined as the time between start of treatment and the first documentation of recurrence, progression, or death for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Overall Survival (OS)	Up to 3 years	OS defined as the time between the start of treatment and death from any cause for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Cycle 1 Day 1 (C1D1), from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; Cycle 2 Day 1 (C2D1), from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose	The pharmacokinetic (PK) profile included determination of Tmax in serum Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with camidanlumab tesirine in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration is discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose	PK profile included AUC0-last of ADCT-301 in Serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	C1D1, from Pre-dose to 4hr, 96hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose	The PK profile included AUCinf of ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Countries

Belgium, United Kingdom, United States

Participant flow

Recruitment details

Participants were enrolled at 9 study centers in 3 countries, including the United States, Belgium, and the United Kingdom, from November 2018 to December 2022.

Pre-assignment details

In part 1, participants were to receive escalating doses of camidanlumab tesirine as monotherapy or escalating doses of camidanlumab tesirine in combination with pembrolizumab, guided by a 3+3 design. The study was terminated prior to enrollment for Part 2 of the study.

Participants by arm

Arm	Count
ADCT-301 Monotherapy 20 µg/kg Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.	3
ADCT-301 Monotherapy 30 µg/kg Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.	5
ADCT-301 Monotherapy 45 µg/kg Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.	5
ADCT-301 Monotherapy 60 µg/kg Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.	5
ADCT-301 Monotherapy 80 µg/kg Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle..	8
ADCT-301 Monotherapy 100 µg/kg Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.	7
ADCT-301 Monotherapy 125 µg/kg Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.	8
ADCT-301 Monotherapy 150 µg/kg Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.	3
ADCT-301 Combination Therapy 20 µg/kg + Pemb Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).	1
ADCT-301 Combination Therapy 30 µg/kg + Pemb Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).	4
ADCT-301 Combination Therapy 45 µg/kg + Pemb Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).	10
ADCT-301 Combination Therapy 60 µg/kg + Pemb Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).	9
ADCT-301 Combination Therapy 80 µg/kg +Pemb Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).	4
ADCT-301 Combination Therapy 100 µg/kg + Pemb Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).	6
Total	78

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG013
Overall Study	Death	2	4	4	3	8	4	6	3	0	3	8	4	2	2
Overall Study	Investigator/Sponsor decision	0	0	0	0	0	0	0	0	0	0	0	4	0	2
Overall Study	Lost to Follow-up	0	0	1	0	0	0	1	0	0	1	0	0	0	0
Overall Study	Withdrawal by Subject	1	0	0	1	0	1	1	0	1	0	2	1	2	2

Baseline characteristics

Characteristic	Total	ADCT-301 Monotherapy 30 µg/kg	ADCT-301 Monotherapy 45 µg/kg	ADCT-301 Monotherapy 60 µg/kg	ADCT-301 Monotherapy 20 µg/kg	ADCT-301 Monotherapy 80 µg/kg	ADCT-301 Monotherapy 100 µg/kg	ADCT-301 Monotherapy 125 µg/kg	ADCT-301 Monotherapy 150 µg/kg	ADCT-301 Combination Therapy 20 µg/kg + Pemb	ADCT-301 Combination Therapy 30 µg/kg + Pemb	ADCT-301 Combination Therapy 45 µg/kg + Pemb	ADCT-301 Combination Therapy 60 µg/kg + Pemb	ADCT-301 Combination Therapy 80 µg/kg +Pemb	ADCT-301 Combination Therapy 100 µg/kg + Pemb
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	36 Participants	3 Participants	1 Participants	2 Participants	1 Participants	4 Participants	5 Participants	2 Participants	0 Participants	1 Participants	1 Participants	5 Participants	7 Participants	2 Participants	2 Participants
Age, Categorical Between 18 and 65 years	42 Participants	2 Participants	4 Participants	3 Participants	2 Participants	4 Participants	2 Participants	6 Participants	3 Participants	0 Participants	3 Participants	5 Participants	2 Participants	2 Participants	4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants	4 Participants	5 Participants	5 Participants	2 Participants	8 Participants	7 Participants	8 Participants	3 Participants	0 Participants	4 Participants	10 Participants	9 Participants	4 Participants	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	68 Participants	4 Participants	4 Participants	4 Participants	3 Participants	7 Participants	7 Participants	8 Participants	3 Participants	0 Participants	4 Participants	7 Participants	9 Participants	3 Participants	5 Participants
Sex: Female, Male Female	41 Participants	2 Participants	2 Participants	3 Participants	2 Participants	3 Participants	3 Participants	2 Participants	1 Participants	0 Participants	3 Participants	7 Participants	7 Participants	3 Participants	3 Participants
Sex: Female, Male Male	37 Participants	3 Participants	3 Participants	2 Participants	1 Participants	5 Participants	4 Participants	6 Participants	2 Participants	1 Participants	1 Participants	3 Participants	2 Participants	1 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk
deaths Total, all-cause mortality	2 / 3	4 / 5	4 / 5	3 / 5	8 / 8	4 / 7	6 / 8	3 / 3	0 / 1	3 / 4	8 / 10	4 / 9	2 / 4	2 / 6
other Total, other adverse events	3 / 3	5 / 5	5 / 5	5 / 5	8 / 8	7 / 7	8 / 8	3 / 3	1 / 1	4 / 4	10 / 10	9 / 9	4 / 4	6 / 6
serious Total, serious adverse events	2 / 3	1 / 5	2 / 5	3 / 5	3 / 8	1 / 7	3 / 8	3 / 3	1 / 1	3 / 4	5 / 10	8 / 9	2 / 4	5 / 6

Outcome results

Primary

Number of Participants Who Experienced a Dose Interruption

Dose interruption for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.

Time frame: Up to 3 years

Population: Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a Dose Interruption	1 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a Dose Interruption	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a Dose Interruption	0 Participants

Primary

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

For the dose-escalation of ADCT-301 as monotherapy, DLT is defined as any of the following events like hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes. For the dose-escalation of ADCT-301 in combination with pembrolizumab, a DLT is defined as any of the following events ike hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes.

Time frame: Day 1 to Day 21

Population: DLT Analysis Set: The DLT-evaluable analysis set consisted of participants in Part 1 who received study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	1 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	1 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	1 Participants

Primary

Number of Participants Who Experienced a Dose Reduction

Dose reductions for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.

Time frame: Up to 3 years

Population: Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a Dose Reduction	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a Dose Reduction	0 Participants

Primary

Number of Participants Who Experienced a SAE by CTCAE Grade

AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 is mild or asymptomatic, 2 is moderate, 3 is severe, 4 is Life-threatening and 5 is death related to an AE.

Time frame: Up to 3 years

Population: Safety Analysis Set: The Safety analysis set consists of all participants who received study drug. Analysis only included participants with SAEs.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	2 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	1 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	1 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	1 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	2 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	2 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	2 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	1 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	1 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	1 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	2 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	1 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	5 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	7 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	1 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	1 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	1 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Missing	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 5	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 3	4 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced a SAE by CTCAE Grade	Grade 2	1 Participants

Primary

Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade

AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms, 2 is moderate, 3 is severe, 4 is Life-threatening consequences and 5 is death related to an AE.

Time frame: Up to 3 years

Population: Safety Analysis Set: The Safety analysis set consists of all participants who received study drug and experienced TEAEs only.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	3 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	4 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	0 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	1 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	1 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	3 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	2 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	1 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	1 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	1 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	1 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	5 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	1 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	2 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	1 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	2 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	1 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	2 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	1 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	4 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	1 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	1 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	1 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	1 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	1 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	2 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	1 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	2 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	7 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	0 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	1 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	6 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	1 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	2 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	2 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	2 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 5	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 1	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Missing	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 3	5 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 4	0 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade	Grade 2	1 Participants

Primary

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant 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, whichever is earlier. Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.

Time frame: Up to 3 years

Population: Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	3 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	5 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	5 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	5 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	8 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	7 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	8 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	3 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	1 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	4 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	10 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	9 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	4 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	6 Participants

Primary

Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)

A SAE is defined as any 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 or 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.

Time frame: Up to 3 years

Population: Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ADCT-301 Monotherapy 20 µg/kg	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	2 Participants
ADCT-301 Monotherapy 30 µg/kg	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	1 Participants
ADCT-301 Monotherapy 45 µg/kg	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	2 Participants
ADCT-301 Monotherapy 60 µg/kg	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	3 Participants
ADCT-301 Monotherapy 80 µg/kg	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	3 Participants
ADCT-301 Monotherapy 100 µg/kg	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	1 Participants
ADCT-301 Monotherapy 125 µg/kg	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	3 Participants
ADCT-301 Monotherapy 150 µg/kg	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	3 Participants
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	1 Participants
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	3 Participants
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	5 Participants
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	8 Participants
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	2 Participants
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)	5 Participants

Secondary

Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199

The PK profile included AI of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. AI is the ratio of accumulation of a drug under steady state conditions (i.e., after repeated administration) as compared to a single dose. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose

Population: PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment.~The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.~Includes participants with available data at each timepoint.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ADCT-301 Monotherapy 20 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.00 ratio	—
ADCT-301 Monotherapy 20 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.00 ratio	—
ADCT-301 Monotherapy 30 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.00 ratio	Geometric Coefficient of Variation 0.248
ADCT-301 Monotherapy 30 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.00 ratio	Geometric Coefficient of Variation 0.175
ADCT-301 Monotherapy 45 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.00 ratio	—
ADCT-301 Monotherapy 45 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.00 ratio	Geometric Coefficient of Variation 0.124
ADCT-301 Monotherapy 60 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.09 ratio	Geometric Coefficient of Variation 7.42
ADCT-301 Monotherapy 60 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.03 ratio	Geometric Coefficient of Variation 3.59
ADCT-301 Monotherapy 80 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.01 ratio	Geometric Coefficient of Variation 0.621
ADCT-301 Monotherapy 80 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.01 ratio	Geometric Coefficient of Variation 0.819
ADCT-301 Monotherapy 100 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.02 ratio	Geometric Coefficient of Variation 3.12
ADCT-301 Monotherapy 100 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.02 ratio	Geometric Coefficient of Variation 2.41
ADCT-301 Monotherapy 125 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.04 ratio	Geometric Coefficient of Variation 4.67
ADCT-301 Monotherapy 125 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.05 ratio	Geometric Coefficient of Variation 6.87
ADCT-301 Monotherapy 150 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.03 ratio	Geometric Coefficient of Variation 2.39
ADCT-301 Monotherapy 150 µg/kg	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.05 ratio	Geometric Coefficient of Variation 4.03
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.00 ratio	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.10 ratio	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.00 ratio	Geometric Coefficient of Variation 0.123
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.00 ratio	Geometric Coefficient of Variation 0.257
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.01 ratio	Geometric Coefficient of Variation 1.05
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.03 ratio	Geometric Coefficient of Variation 3.73
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.00 ratio	Geometric Coefficient of Variation 0.305
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.00 ratio	Geometric Coefficient of Variation 0.57
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.00 ratio	Geometric Coefficient of Variation 0.258
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.01 ratio	Geometric Coefficient of Variation 0.757
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.04 ratio	Geometric Coefficient of Variation 3.01
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.02 ratio	Geometric Coefficient of Variation 1.28

Secondary

Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

The PK profile included the Thalf of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ADCT-301 Monotherapy 20 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.39 days	—
ADCT-301 Monotherapy 20 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.75 days	—
ADCT-301 Monotherapy 20 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.22 days	—
ADCT-301 Monotherapy 20 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.41 days	—
ADCT-301 Monotherapy 30 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.89 days	Geometric Coefficient of Variation 25.6
ADCT-301 Monotherapy 30 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.93 days	Geometric Coefficient of Variation 40.1
ADCT-301 Monotherapy 30 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.99 days	Geometric Coefficient of Variation 27.1
ADCT-301 Monotherapy 45 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.88 days	—
ADCT-301 Monotherapy 45 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.49 days	Geometric Coefficient of Variation 5.47
ADCT-301 Monotherapy 45 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.10 days	Geometric Coefficient of Variation 17.4
ADCT-301 Monotherapy 45 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.36 days	Geometric Coefficient of Variation 11.2
ADCT-301 Monotherapy 60 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.41 days	Geometric Coefficient of Variation 75.5
ADCT-301 Monotherapy 60 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	3.22 days	Geometric Coefficient of Variation 22.8
ADCT-301 Monotherapy 60 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	3.95 days	Geometric Coefficient of Variation 118
ADCT-301 Monotherapy 60 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.86 days	Geometric Coefficient of Variation 66.3
ADCT-301 Monotherapy 80 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2.49 days	Geometric Coefficient of Variation 29
ADCT-301 Monotherapy 80 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.96 days	Geometric Coefficient of Variation 9.91
ADCT-301 Monotherapy 80 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.67 days	Geometric Coefficient of Variation 29.1
ADCT-301 Monotherapy 80 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.95 days	Geometric Coefficient of Variation 13.7
ADCT-301 Monotherapy 100 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.58 days	Geometric Coefficient of Variation 79.1
ADCT-301 Monotherapy 100 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	3.15 days	Geometric Coefficient of Variation 43.5
ADCT-301 Monotherapy 100 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.30 days	Geometric Coefficient of Variation 54.5
ADCT-301 Monotherapy 100 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2.49 days	Geometric Coefficient of Variation 43.2
ADCT-301 Monotherapy 125 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	3.66 days	Geometric Coefficient of Variation 44.5
ADCT-301 Monotherapy 125 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	3.92 days	Geometric Coefficient of Variation 48.2
ADCT-301 Monotherapy 125 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	4.08 days	Geometric Coefficient of Variation 33.4
ADCT-301 Monotherapy 125 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	3.78 days	Geometric Coefficient of Variation 42.4
ADCT-301 Monotherapy 150 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	4.70 days	Geometric Coefficient of Variation 27.6
ADCT-301 Monotherapy 150 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	3.97 days	Geometric Coefficient of Variation 17.9
ADCT-301 Monotherapy 150 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2.79 days	Geometric Coefficient of Variation 70.8
ADCT-301 Monotherapy 150 µg/kg	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	3.28 days	Geometric Coefficient of Variation 51.7
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.55 days	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	6.09 days	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2.60 days	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.42 days	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.85 days	Geometric Coefficient of Variation 31.9
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2.33 days	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.37 days	Geometric Coefficient of Variation 18.7
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2.16 days	Geometric Coefficient of Variation 16.8
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2.54 days	Geometric Coefficient of Variation 42.4
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	3.13 days	Geometric Coefficient of Variation 47
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.64 days	Geometric Coefficient of Variation 12.8
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2.10 days	Geometric Coefficient of Variation 20
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.93 days	Geometric Coefficient of Variation 20.8
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.24 days	Geometric Coefficient of Variation 22.5
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2.24 days	Geometric Coefficient of Variation 29.7
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2.30 days	Geometric Coefficient of Variation 21.4
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.61 days	Geometric Coefficient of Variation 9.3
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2.55 days	Geometric Coefficient of Variation 13
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.97 days	Geometric Coefficient of Variation 20.1
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	3.00 days	Geometric Coefficient of Variation 18.9
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	3.98 days	Geometric Coefficient of Variation 35.1
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	3.32 days	Geometric Coefficient of Variation 20
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.89 days	Geometric Coefficient of Variation 41.8

Secondary

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

The PK profile included AUCinf of ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: C1D1, from Pre-dose to 4hr, 96hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ADCT-301 Monotherapy 20 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1068 day*µg/L	—
ADCT-301 Monotherapy 20 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	823 day*µg/L	—
ADCT-301 Monotherapy 30 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	907 day*µg/L	Geometric Coefficient of Variation 26.6
ADCT-301 Monotherapy 45 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1000 day*µg/L	Geometric Coefficient of Variation 14.7
ADCT-301 Monotherapy 45 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1331 day*µg/L	Geometric Coefficient of Variation 2.4
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	5768 day*µg/L	Geometric Coefficient of Variation 10.7
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2552 day*µg/L	Geometric Coefficient of Variation 98.1
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2259 day*µg/L	Geometric Coefficient of Variation 30.1
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	3962 day*µg/L	Geometric Coefficient of Variation 21.8
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	6594 day*µg/L	Geometric Coefficient of Variation 36.2
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	3708 day*µg/L	Geometric Coefficient of Variation 66
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	7420 day*µg/L	Geometric Coefficient of Variation 30.9
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	13018 day*µg/L	Geometric Coefficient of Variation 40.3
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	9578 day*µg/L	Geometric Coefficient of Variation 50.1
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	8031 day*µg/L	Geometric Coefficient of Variation 22.6
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	678 day*µg/L	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2107 day*µg/L	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	873 day*µg/L	—
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2058 day*µg/L	Geometric Coefficient of Variation 19.7
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2083 day*µg/L	Geometric Coefficient of Variation 18.4
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	3552 day*µg/L	Geometric Coefficient of Variation 23.6
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2059 day*µg/L	Geometric Coefficient of Variation 30.1
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2725 day*µg/L	Geometric Coefficient of Variation 51.5
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	4157 day*µg/L	Geometric Coefficient of Variation 77.3
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	7077 day*µg/L	Geometric Coefficient of Variation 8.27
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	4556 day*µg/L	Geometric Coefficient of Variation 34.4

Secondary

Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

The PK profile included AUCtau ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ADCT-301 Monotherapy 20 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2562 day*µg/L	—
ADCT-301 Monotherapy 20 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1776 day*µg/L	—
ADCT-301 Monotherapy 30 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1302 day*µg/L	Geometric Coefficient of Variation 88.4
ADCT-301 Monotherapy 30 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1110 day*µg/L	Geometric Coefficient of Variation 70.5
ADCT-301 Monotherapy 45 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1516 day*µg/L	—
ADCT-301 Monotherapy 45 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2217 day*µg/L	Geometric Coefficient of Variation 34.2
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	4490 day*µg/L	Geometric Coefficient of Variation 110
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	3719 day*µg/L	Geometric Coefficient of Variation 132
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2956 day*µg/L	Geometric Coefficient of Variation 47.2
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	5565 day*µg/L	Geometric Coefficient of Variation 35.4
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	6486 day*µg/L	Geometric Coefficient of Variation 80
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	6084 day*µg/L	Geometric Coefficient of Variation 26.4
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	13483 day*µg/L	Geometric Coefficient of Variation 22.9
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	9238 day*µg/L	Geometric Coefficient of Variation 27.5
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	7885 day*µg/L	Geometric Coefficient of Variation 31.4
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	12197 day*µg/L	Geometric Coefficient of Variation 40.7
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	5399 day*µg/L	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2882 day*µg/L	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1171 day*µg/L	Geometric Coefficient of Variation 5.95
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1856 day*µg/L	Geometric Coefficient of Variation 4.69
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2861 day*µg/L	Geometric Coefficient of Variation 43.3
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1816 day*µg/L	Geometric Coefficient of Variation 46.1
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	3720 day*µg/L	Geometric Coefficient of Variation 47.5
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2467 day*µg/L	Geometric Coefficient of Variation 44.6
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	4887 day*µg/L	Geometric Coefficient of Variation 27.6
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2975 day*µg/L	Geometric Coefficient of Variation 18.4
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	8920 day*µg/L	Geometric Coefficient of Variation 45.4
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	5440 day*µg/L	Geometric Coefficient of Variation 64.1
Unknown	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	— day*µg/L	—
Unknown	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	— day*µg/L	—
Unknown	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	— day*µg/L	—
Unknown	Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	— day*µg/L	—

Secondary

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

PK profile included AUC0-last of ADCT-301 in Serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ADCT-301 Monotherapy 20 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	294 day*ng/mL	Geometric Coefficient of Variation 598
ADCT-301 Monotherapy 20 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	769 day*ng/mL	Geometric Coefficient of Variation 14.6
ADCT-301 Monotherapy 20 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	588 day*ng/mL	Geometric Coefficient of Variation 17.3
ADCT-301 Monotherapy 20 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	229 day*ng/mL	Geometric Coefficient of Variation 520
ADCT-301 Monotherapy 30 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	880 day*ng/mL	Geometric Coefficient of Variation 107
ADCT-301 Monotherapy 30 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	464 day*ng/mL	Geometric Coefficient of Variation 65.8
ADCT-301 Monotherapy 30 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	676 day*ng/mL	Geometric Coefficient of Variation 92.4
ADCT-301 Monotherapy 30 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	636 day*ng/mL	Geometric Coefficient of Variation 113
ADCT-301 Monotherapy 45 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	647 day*ng/mL	Geometric Coefficient of Variation 222
ADCT-301 Monotherapy 45 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1060 day*ng/mL	Geometric Coefficient of Variation 105
ADCT-301 Monotherapy 45 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	484 day*ng/mL	Geometric Coefficient of Variation 224
ADCT-301 Monotherapy 45 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	898 day*ng/mL	Geometric Coefficient of Variation 95.5
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2067 day*ng/mL	Geometric Coefficient of Variation 93.6
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	3740 day*ng/mL	Geometric Coefficient of Variation 116
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2386 day*ng/mL	Geometric Coefficient of Variation 126
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.00100 day*ng/mL	—
ADCT-301 Monotherapy 60 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2857 day*ng/mL	Geometric Coefficient of Variation 67.7
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.00400 day*ng/mL	Geometric Coefficient of Variation 1630
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.00100 day*ng/mL	Geometric Coefficient of Variation 322
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	3025 day*ng/mL	Geometric Coefficient of Variation 37
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2668 day*ng/mL	Geometric Coefficient of Variation 44
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1954 day*ng/mL	Geometric Coefficient of Variation 31.9
ADCT-301 Monotherapy 80 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	4910 day*ng/mL	Geometric Coefficient of Variation 35.8
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	3440 day*ng/mL	Geometric Coefficient of Variation 66.6
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	4938 day*ng/mL	Geometric Coefficient of Variation 67.4
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.00600 day*ng/mL	Geometric Coefficient of Variation 751
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	4025 day*ng/mL	Geometric Coefficient of Variation 101
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	5815 day*ng/mL	Geometric Coefficient of Variation 72.2
ADCT-301 Monotherapy 100 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.00200 day*ng/mL	Geometric Coefficient of Variation 14068
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0320 day*ng/mL	Geometric Coefficient of Variation 3.13
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	5848 day*ng/mL	Geometric Coefficient of Variation 53.5
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.00300 day*ng/mL	Geometric Coefficient of Variation 298
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	8305 day*ng/mL	Geometric Coefficient of Variation 22
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	8812 day*ng/mL	Geometric Coefficient of Variation 74.6
ADCT-301 Monotherapy 125 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	11879 day*ng/mL	Geometric Coefficient of Variation 18.8
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	6599 day*ng/mL	Geometric Coefficient of Variation 46.1
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	9078 day*ng/mL	Geometric Coefficient of Variation 48.4
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	9027 day*ng/mL	Geometric Coefficient of Variation 48
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.00100 day*ng/mL	—
ADCT-301 Monotherapy 150 µg/kg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	5571 day*ng/mL	Geometric Coefficient of Variation 61.9
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	564 day*ng/mL	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	955 day*ng/mL	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2421 day*ng/mL	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	4796 day*ng/mL	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	655 day*ng/mL	Geometric Coefficient of Variation 53.6
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	825 day*ng/mL	Geometric Coefficient of Variation 37.6
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1128 day*ng/mL	Geometric Coefficient of Variation 47.5
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	965 day*ng/mL	Geometric Coefficient of Variation 73.7
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1392 day*ng/mL	Geometric Coefficient of Variation 57
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1124 day*ng/mL	Geometric Coefficient of Variation 47
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.00600 day*ng/mL	—
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0110 day*ng/mL	—
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1508 day*ng/mL	Geometric Coefficient of Variation 52.7
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1653 day*ng/mL	Geometric Coefficient of Variation 57.3
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.00300 day*ng/mL	Geometric Coefficient of Variation 293
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2470 day*ng/mL	Geometric Coefficient of Variation 42.1
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.00100 day*ng/mL	—
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1737 day*ng/mL	Geometric Coefficient of Variation 35.6
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2609 day*ng/mL	Geometric Coefficient of Variation 74.9
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1716 day*ng/mL	Geometric Coefficient of Variation 84.6
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1386 day*ng/mL	Geometric Coefficient of Variation 145
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	3203 day*ng/mL	Geometric Coefficient of Variation 41.3
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.00300 day*ng/mL	—
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1172 day*ng/mL	Geometric Coefficient of Variation 557
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	814 day*ng/mL	Geometric Coefficient of Variation 428
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.00100 day*ng/mL	Geometric Coefficient of Variation 57.2
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	4535 day*ng/mL	Geometric Coefficient of Variation 66.2
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	3863 day*ng/mL	Geometric Coefficient of Variation 33.3
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.00200 day*ng/mL	Geometric Coefficient of Variation 228
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	7274 day*ng/mL	Geometric Coefficient of Variation 24
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.00100 day*ng/mL	—
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	7077 day*ng/mL	Geometric Coefficient of Variation 44.1

Secondary

Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199

The PK profile included the CL of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ADCT-301 Monotherapy 20 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.940 L/day	—
ADCT-301 Monotherapy 20 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.544 L/day	—
ADCT-301 Monotherapy 20 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.449 L/day	—
ADCT-301 Monotherapy 20 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.869 L/day	—
ADCT-301 Monotherapy 30 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2.02 L/day	Geometric Coefficient of Variation 69.3
ADCT-301 Monotherapy 30 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.85 L/day	Geometric Coefficient of Variation 74
ADCT-301 Monotherapy 30 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2.05 L/day	Geometric Coefficient of Variation 86.9
ADCT-301 Monotherapy 45 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2.60 L/day	Geometric Coefficient of Variation 3.98
ADCT-301 Monotherapy 45 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.91 L/day	—
ADCT-301 Monotherapy 45 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.92 L/day	Geometric Coefficient of Variation 15.9
ADCT-301 Monotherapy 45 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.43 L/day	Geometric Coefficient of Variation 48
ADCT-301 Monotherapy 60 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.37 L/day	Geometric Coefficient of Variation 60.5
ADCT-301 Monotherapy 60 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.928 L/day	Geometric Coefficient of Variation 0.345
ADCT-301 Monotherapy 60 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.01 L/day	Geometric Coefficient of Variation 105
ADCT-301 Monotherapy 60 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.02 L/day	Geometric Coefficient of Variation 88.1
ADCT-301 Monotherapy 80 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.04 L/day	Geometric Coefficient of Variation 18.3
ADCT-301 Monotherapy 80 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.994 L/day	Geometric Coefficient of Variation 20.9
ADCT-301 Monotherapy 80 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.35 L/day	Geometric Coefficient of Variation 27.8
ADCT-301 Monotherapy 80 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.57 L/day	Geometric Coefficient of Variation 18.3
ADCT-301 Monotherapy 100 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.25 L/day	Geometric Coefficient of Variation 64.9
ADCT-301 Monotherapy 100 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.18 L/day	Geometric Coefficient of Variation 21.2
ADCT-301 Monotherapy 100 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.84 L/day	Geometric Coefficient of Variation 52.7
ADCT-301 Monotherapy 100 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.24 L/day	Geometric Coefficient of Variation 32.8
ADCT-301 Monotherapy 125 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.02 L/day	Geometric Coefficient of Variation 19.9
ADCT-301 Monotherapy 125 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.22 L/day	Geometric Coefficient of Variation 16.4
ADCT-301 Monotherapy 125 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.830 L/day	Geometric Coefficient of Variation 15.4
ADCT-301 Monotherapy 125 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.880 L/day	Geometric Coefficient of Variation 27.4
ADCT-301 Monotherapy 150 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.04 L/day	Geometric Coefficient of Variation 26.5
ADCT-301 Monotherapy 150 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.36 L/day	Geometric Coefficient of Variation 12.8
ADCT-301 Monotherapy 150 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.16 L/day	Geometric Coefficient of Variation 18.9
ADCT-301 Monotherapy 150 µg/kg	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.16 L/day	Geometric Coefficient of Variation 17.3
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.53 L/day	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.16 L/day	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.82 L/day	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2.30 L/day	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2.11 L/day	Geometric Coefficient of Variation 6.07
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.15 L/day	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.58 L/day	Geometric Coefficient of Variation 16.8
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.27 L/day	Geometric Coefficient of Variation 21
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.44 L/day	Geometric Coefficient of Variation 35.4
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.08 L/day	Geometric Coefficient of Variation 28.9
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.35 L/day	Geometric Coefficient of Variation 22.6
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.12 L/day	Geometric Coefficient of Variation 24.4
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.33 L/day	Geometric Coefficient of Variation 34.4
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.13 L/day	Geometric Coefficient of Variation 36.7
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.43 L/day	Geometric Coefficient of Variation 43.1
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.47 L/day	Geometric Coefficient of Variation 10.9
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.46 L/day	Geometric Coefficient of Variation 40.3
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1.14 L/day	Geometric Coefficient of Variation 63.2
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1.07 L/day	Geometric Coefficient of Variation 19.8
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.809 L/day	Geometric Coefficient of Variation 13.1
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.890 L/day	Geometric Coefficient of Variation 15.3
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1.23 L/day	Geometric Coefficient of Variation 30.7
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1.36 L/day	Geometric Coefficient of Variation 31.5

Secondary

Duration of Response (DOR) as Per RECIST v 1.1

DOR is defined among objective responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression (based on radiographic or clinical progression at end of treatment \[EOT\]/end of study \[EOS\]) or death due to any cause.

Time frame: Up to 3 years

Population: Efficacy Analysis Set: This analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. Participants who did not have a post-Baseline assessment due to early clinical progression or death were also included. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.~Includes participants who experienced CR or PR only.

Arm	Measure	Value (MEDIAN)
ADCT-301 Monotherapy 30 µg/kg	Duration of Response (DOR) as Per RECIST v 1.1	9.26 months

Secondary

Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199

The PK profile included determination of Cmax in serum Total antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ADCT-301 Monotherapy 20 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	317 µg/L	Geometric Coefficient of Variation 33.2
ADCT-301 Monotherapy 20 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	405 µg/L	Geometric Coefficient of Variation 12.8
ADCT-301 Monotherapy 20 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	411 µg/L	Geometric Coefficient of Variation 39.2
ADCT-301 Monotherapy 20 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	490 µg/L	Geometric Coefficient of Variation 2.6
ADCT-301 Monotherapy 30 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	377 µg/L	Geometric Coefficient of Variation 35.7
ADCT-301 Monotherapy 30 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	560 µg/L	Geometric Coefficient of Variation 122
ADCT-301 Monotherapy 30 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	448 µg/L	Geometric Coefficient of Variation 109
ADCT-301 Monotherapy 30 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	314 µg/L	Geometric Coefficient of Variation 34.2
ADCT-301 Monotherapy 45 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	497 µg/L	Geometric Coefficient of Variation 28.6
ADCT-301 Monotherapy 45 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	552 µg/L	Geometric Coefficient of Variation 31.5
ADCT-301 Monotherapy 45 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	433 µg/L	Geometric Coefficient of Variation 35
ADCT-301 Monotherapy 45 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	592 µg/L	Geometric Coefficient of Variation 24.7
ADCT-301 Monotherapy 60 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	999 µg/L	Geometric Coefficient of Variation 78.3
ADCT-301 Monotherapy 60 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1420 µg/L	Geometric Coefficient of Variation 62.3
ADCT-301 Monotherapy 60 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1077 µg/L	Geometric Coefficient of Variation 23.7
ADCT-301 Monotherapy 60 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	889 µg/L	Geometric Coefficient of Variation 34.3
ADCT-301 Monotherapy 60 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0130 µg/L	—
ADCT-301 Monotherapy 80 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	901 µg/L	Geometric Coefficient of Variation 33.6
ADCT-301 Monotherapy 80 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1354 µg/L	Geometric Coefficient of Variation 22.9
ADCT-301 Monotherapy 80 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1270 µg/L	Geometric Coefficient of Variation 28.6
ADCT-301 Monotherapy 80 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0130 µg/L	Geometric Coefficient of Variation 3.82
ADCT-301 Monotherapy 80 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0120 µg/L	Geometric Coefficient of Variation 28.3
ADCT-301 Monotherapy 80 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	939 µg/L	Geometric Coefficient of Variation 34.5
ADCT-301 Monotherapy 100 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1328 µg/L	Geometric Coefficient of Variation 38
ADCT-301 Monotherapy 100 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1740 µg/L	Geometric Coefficient of Variation 32.5
ADCT-301 Monotherapy 100 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0110 µg/L	Geometric Coefficient of Variation 3.23
ADCT-301 Monotherapy 100 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1527 µg/L	Geometric Coefficient of Variation 43.7
ADCT-301 Monotherapy 100 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0170 µg/L	Geometric Coefficient of Variation 35.8
ADCT-301 Monotherapy 100 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1797 µg/L	Geometric Coefficient of Variation 35.1
ADCT-301 Monotherapy 125 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0170 µg/L	Geometric Coefficient of Variation 8.29
ADCT-301 Monotherapy 125 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	2017 µg/L	Geometric Coefficient of Variation 20.4
ADCT-301 Monotherapy 125 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2624 µg/L	Geometric Coefficient of Variation 2.67
ADCT-301 Monotherapy 125 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2442 µg/L	Geometric Coefficient of Variation 25.6
ADCT-301 Monotherapy 125 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2150 µg/L	Geometric Coefficient of Variation 11.1
ADCT-301 Monotherapy 125 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0140 µg/L	Geometric Coefficient of Variation 21.8
ADCT-301 Monotherapy 150 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2228 µg/L	Geometric Coefficient of Variation 18.2
ADCT-301 Monotherapy 150 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0140 µg/L	—
ADCT-301 Monotherapy 150 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1990 µg/L	Geometric Coefficient of Variation 1.73
ADCT-301 Monotherapy 150 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	2208 µg/L	Geometric Coefficient of Variation 13.2
ADCT-301 Monotherapy 150 µg/kg	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	2907 µg/L	Geometric Coefficient of Variation 7.98
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1270 µg/L	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	408 µg/L	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	488 µg/L	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1660 µg/L	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	463 µg/L	Geometric Coefficient of Variation 44.6
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	507 µg/L	Geometric Coefficient of Variation 25.8
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	407 µg/L	Geometric Coefficient of Variation 43
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	389 µg/L	Geometric Coefficient of Variation 31.3
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	603 µg/L	Geometric Coefficient of Variation 38.5
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0110 µg/L	—
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	719 µg/L	Geometric Coefficient of Variation 39.2
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	745 µg/L	Geometric Coefficient of Variation 29.7
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0100 µg/L	—
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	594 µg/L	Geometric Coefficient of Variation 46.2
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1149 µg/L	Geometric Coefficient of Variation 71.1
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	750 µg/L	Geometric Coefficient of Variation 17.1
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	946 µg/L	Geometric Coefficient of Variation 18.8
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0120 µg/L	—
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	862 µg/L	Geometric Coefficient of Variation 82.7
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0100 µg/L	Geometric Coefficient of Variation 26.4
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1355 µg/L	Geometric Coefficient of Variation 128
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	954 µg/L	Geometric Coefficient of Variation 75
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0130 µg/L	Geometric Coefficient of Variation 5.97
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	1209 µg/L	Geometric Coefficient of Variation 76.2
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0190 µg/L	—
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1089 µg/L	Geometric Coefficient of Variation 125
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	1297 µg/L	Geometric Coefficient of Variation 46.4
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0250 µg/L	Geometric Coefficient of Variation 185
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 1	2836 µg/L	Geometric Coefficient of Variation 126
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	1937 µg/L	Geometric Coefficient of Variation 150
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Total Antibody Cycle 2	1690 µg/L	Geometric Coefficient of Variation 24.9
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0120 µg/L	—

Secondary

Number of Participants With Anti-drug Antibody (ADA) Response in Serum

ADA testing included number of participants with positive pre-dose ADA response, number of participants with post-dose ADA response only, and number of participants with positive ADA response at any time. Collection of ADA was stopped if ADCT-301 administration was discontinued. For participants treated with ADCT-301 in combination with pembrolizumab, unless there was a penultimate observation of positive ADA response, no other collection of ADA data was necessary if ADCT-301 administration was discontinued. Upon consultation with the Sponsor, ADA samples were not collected anymore if ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: C1D1, from Pre-dose to 336 hr post dose.

Population: Pharmacodynamic Analysis Set: The pharmacodynamic analysis set consisted of all participants who received study drug and had at least 1 valid pharmacodynamics/biomarker assessment. The data was pooled overall as pre-specified in protocol.~Includes participants with available data at each timepoint.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
ADCT-301 Monotherapy 20 µg/kg	Number of Participants With Anti-drug Antibody (ADA) Response in Serum	Positive ADA predose	1 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants With Anti-drug Antibody (ADA) Response in Serum	Positive ADA post dose	0 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants With Anti-drug Antibody (ADA) Response in Serum	Positive ADA at any time	1 Participants
ADCT-301 Monotherapy 20 µg/kg	Number of Participants With Anti-drug Antibody (ADA) Response in Serum	Positive ADA before and after dose	1 Participants

Secondary

Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

The ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The overall response category was derived based on response assessment performed on or before the start of subsequent anti-cancer therapy.

Time frame: Up to 3 years

Population: Efficacy Analysis Set: The Efficacy analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. Participants who did not have a post-Baseline assessment due to early clinical progression or death (after receiving study drug) were also included. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.

Arm	Measure	Value (NUMBER)
ADCT-301 Monotherapy 20 µg/kg	Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	0 percentage of participants
ADCT-301 Monotherapy 30 µg/kg	Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	15.2 percentage of participants

Secondary

Overall Survival (OS)

OS defined as the time between the start of treatment and death from any cause for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.

Time frame: Up to 3 years

Population: Efficacy Analysis Set: The Efficacy analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.

Arm	Measure	Value (MEDIAN)
ADCT-301 Monotherapy 20 µg/kg	Overall Survival (OS)	4.37 months
ADCT-301 Monotherapy 30 µg/kg	Overall Survival (OS)	7.59 months

Secondary

Progression-free Survival (PFS) as Per RECIST v 1.1

PFS defined as the time between start of treatment and the first documentation of recurrence, progression, or death for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.

Time frame: Up to 3 years

Population: Efficacy Analysis Set: The Efficacy analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.

Arm	Measure	Value (MEDIAN)
ADCT-301 Monotherapy 20 µg/kg	Progression-free Survival (PFS) as Per RECIST v 1.1	1.35 months
ADCT-301 Monotherapy 30 µg/kg	Progression-free Survival (PFS) as Per RECIST v 1.1	1.41 months

Secondary

Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

The pharmacokinetic (PK) profile included determination of Tmax in serum Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with camidanlumab tesirine in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration is discontinued and pembrolizumab continues. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Time frame: Cycle 1 Day 1 (C1D1), from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; Cycle 2 Day 1 (C2D1), from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose

Population: PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment. Includes participants with available data at each timepoint.~The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.~Includes participants with available data at each timepoint.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ADCT-301 Monotherapy 20 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0750 days	Geometric Coefficient of Variation 81.1
ADCT-301 Monotherapy 20 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0670 days	Geometric Coefficient of Variation 193
ADCT-301 Monotherapy 20 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0750 days	Geometric Coefficient of Variation 81.1
ADCT-301 Monotherapy 20 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0670 days	Geometric Coefficient of Variation 193
ADCT-301 Monotherapy 30 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0770 days	Geometric Coefficient of Variation 82.4
ADCT-301 Monotherapy 30 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0280 days	Geometric Coefficient of Variation 33.1
ADCT-301 Monotherapy 30 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0280 days	Geometric Coefficient of Variation 33.1
ADCT-301 Monotherapy 30 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0980 days	Geometric Coefficient of Variation 87.2
ADCT-301 Monotherapy 45 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0440 days	Geometric Coefficient of Variation 122
ADCT-301 Monotherapy 45 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0720 days	Geometric Coefficient of Variation 130
ADCT-301 Monotherapy 45 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0780 days	Geometric Coefficient of Variation 76.2
ADCT-301 Monotherapy 45 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0780 days	Geometric Coefficient of Variation 76.2
ADCT-301 Monotherapy 60 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0730 days	Geometric Coefficient of Variation 54.2
ADCT-301 Monotherapy 60 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0940 days	Geometric Coefficient of Variation 54.8
ADCT-301 Monotherapy 60 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.115 days	Geometric Coefficient of Variation 94.2
ADCT-301 Monotherapy 60 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.168 days	—
ADCT-301 Monotherapy 60 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0760 days	Geometric Coefficient of Variation 115
ADCT-301 Monotherapy 80 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.112 days	Geometric Coefficient of Variation 91.9
ADCT-301 Monotherapy 80 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0280 days	Geometric Coefficient of Variation 15.7
ADCT-301 Monotherapy 80 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.174 days	Geometric Coefficient of Variation 0
ADCT-301 Monotherapy 80 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0560 days	Geometric Coefficient of Variation 50.3
ADCT-301 Monotherapy 80 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0790 days	Geometric Coefficient of Variation 70.2
ADCT-301 Monotherapy 80 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.146 days	Geometric Coefficient of Variation 37.8
ADCT-301 Monotherapy 100 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0760 days	Geometric Coefficient of Variation 37
ADCT-301 Monotherapy 100 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0910 days	Geometric Coefficient of Variation 56.3
ADCT-301 Monotherapy 100 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.116 days	Geometric Coefficient of Variation 54.4
ADCT-301 Monotherapy 100 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0550 days	Geometric Coefficient of Variation 79.5
ADCT-301 Monotherapy 100 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.280 days	Geometric Coefficient of Variation 4298
ADCT-301 Monotherapy 100 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0540 days	Geometric Coefficient of Variation 78.3
ADCT-301 Monotherapy 125 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0840 days	Geometric Coefficient of Variation 48.6
ADCT-301 Monotherapy 125 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.170 days	Geometric Coefficient of Variation 3.17
ADCT-301 Monotherapy 125 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0310 days	Geometric Coefficient of Variation 1.12
ADCT-301 Monotherapy 125 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.192 days	Geometric Coefficient of Variation 18.6
ADCT-301 Monotherapy 125 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0310 days	Geometric Coefficient of Variation 1.12
ADCT-301 Monotherapy 125 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0700 days	Geometric Coefficient of Variation 43.1
ADCT-301 Monotherapy 150 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0770 days	Geometric Coefficient of Variation 87.8
ADCT-301 Monotherapy 150 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0860 days	Geometric Coefficient of Variation 173
ADCT-301 Monotherapy 150 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.121 days	Geometric Coefficient of Variation 65.9
ADCT-301 Monotherapy 150 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.160 days	—
ADCT-301 Monotherapy 150 µg/kg	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0470 days	Geometric Coefficient of Variation 160
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0350 days	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0350 days	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0330 days	—
ADCT-301 Combination Therapy 20 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0330 days	—
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0430 days	Geometric Coefficient of Variation 112
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0740 days	Geometric Coefficient of Variation 92.5
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0290 days	Geometric Coefficient of Variation 15.9
ADCT-301 Combination Therapy 30 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0740 days	Geometric Coefficient of Variation 92.5
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.0690 days	Geometric Coefficient of Variation 112
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.110 days	Geometric Coefficient of Variation 542
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0720 days	Geometric Coefficient of Variation 1522
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0830 days	Geometric Coefficient of Variation 112
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	2.84 days	—
ADCT-301 Combination Therapy 45 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	1.12 days	—
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0590 days	Geometric Coefficient of Variation 131
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.178 days	—
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.112 days	Geometric Coefficient of Variation 99.6
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.108 days	Geometric Coefficient of Variation 114
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.102 days	Geometric Coefficient of Variation 106
ADCT-301 Combination Therapy 60 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.169 days	Geometric Coefficient of Variation 2.32
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.0620 days	Geometric Coefficient of Variation 163
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.0320 days	—
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.101 days	Geometric Coefficient of Variation 130
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.0510 days	Geometric Coefficient of Variation 147
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.161 days	Geometric Coefficient of Variation 1.52
ADCT-301 Combination Therapy 80 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.0620 days	Geometric Coefficient of Variation 163
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 1	0.121 days	Geometric Coefficient of Variation 90.2
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 1	0.0890 days	Geometric Coefficient of Variation 152
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 2	0.171 days	Geometric Coefficient of Variation 9.93
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Unconjugated SG3199 Cycle 2	0.161 days	—
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Total Antibody Cycle 1	0.121 days	Geometric Coefficient of Variation 90.2
ADCT-301 Combination Therapy 100 µg/kg + Pemb	Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199	Conjugated Antibody Cycle 2	0.171 days	Geometric Coefficient of Variation 9.93

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants Who Experienced a Dose Interruption

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

Number of Participants Who Experienced a Dose Reduction

Number of Participants Who Experienced a SAE by CTCAE Grade

Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)

Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199

Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199

Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199

Duration of Response (DOR) as Per RECIST v 1.1

Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199

Number of Participants With Anti-drug Antibody (ADA) Response in Serum

Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

Overall Survival (OS)

Progression-free Survival (PFS) as Per RECIST v 1.1

Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199