Trial Outcomes & Findings for Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma (NCT NCT03685344)

NCT ID: NCT03685344

Last Updated: 2021-10-26

Results Overview

A TEAE was defined as an adverse event (AE) that occurred or worsened in the period extending from the first dose of study drugs to 30 days after the last dose of study drugs or initiation of new anti-cancer therapy (whichever occurred earlier). Evaluation of TEAEs included the number of participants with at least one: TEAE, serious TEAE and grade ≥3 TEAE as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 CTCAE grading scale: * Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. * Grade 4 = Life-threatening consequences; urgent intervention indicated. * Grade 5 = Death related to AE. Clinically significant changes from baseline for safety laboratory values, vital sign measurements and electrocardiograms (ECGs) were recorded as TEAEs.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: Day 1 to 30 days after the last dose of study drugs (maximum treatment duration at study termination was 336 days)
• Results posted on: 2021-10-26

Participant Flow

13 participants were enrolled at 5 sites in the United States and 3 sites in Spain between February 2019 and October 2020.

16 participants had signed informed consent, however 3 were considered screen failures. The remaining 13 participants were enrolled and received study treatment.

Participant milestones

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Overall Study STARTED	3	3	7	0
Overall Study Received Treatment	3	3	7	0
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	3	3	7	0

Reasons for withdrawal

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Overall Study Withdrawal by Subject	1	1	2	0
Overall Study Physician Decision	1	1	5	0
Overall Study Death	1	1	0	0

Baseline Characteristics

Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma

Baseline characteristics by cohort

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.	Total n=13 Participants Total of all reporting groups
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	—	6 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	—	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	—	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	—	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	—	11 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	—	2 Participants n=21 Participants
Age, Continuous	66.0 years STANDARD_DEVIATION 15.00 • n=5 Participants	74.0 years STANDARD_DEVIATION 2.00 • n=7 Participants	63.0 years STANDARD_DEVIATION 16.94 • n=5 Participants	—	66.2 years STANDARD_DEVIATION 14.24 • n=21 Participants

PRIMARY outcome

Timeframe: Day 1 to 30 days after the last dose of study drugs (maximum treatment duration at study termination was 336 days)

Population: Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

A TEAE was defined as an adverse event (AE) that occurred or worsened in the period extending from the first dose of study drugs to 30 days after the last dose of study drugs or initiation of new anti-cancer therapy (whichever occurred earlier).

Evaluation of TEAEs included the number of participants with at least one: TEAE, serious TEAE and grade ≥3 TEAE as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

CTCAE grading scale:

• Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living.
• Grade 4 = Life-threatening consequences; urgent intervention indicated.
• Grade 5 = Death related to AE.

Clinically significant changes from baseline for safety laboratory values, vital sign measurements and electrocardiograms (ECGs) were recorded as TEAEs.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Number of Participants With a Treatment-emergent Adverse Event (TEAE) TEAE	3 Participants	3 Participants	7 Participants	—
Number of Participants With a Treatment-emergent Adverse Event (TEAE) Serious TEAE	1 Participants	2 Participants	1 Participants	—
Number of Participants With a Treatment-emergent Adverse Event (TEAE) CTCAE Grade ≥3 TEAE	2 Participants	2 Participants	5 Participants	—

PRIMARY outcome

Timeframe: 21 days after first dose of durvalumab (Day 8 to Day 29)

Population: Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

DLTs were defined as specific events which occurred in the 21-day DLT evaluation period of the dose escalation part, except any events that were clearly due to underlying disease or extraneous causes. The grading and severity of events were based on the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Number of Participants With a Dose-limiting Toxicity	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Day 1 to end of treatment (maximum treatment duration at study termination was 336 days)

Population: Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Number of Participants With a Treatment-emergent Adverse Event Leading to Dose Interruption or Reduction Durvalumab: Dose Interruption	0 Participants	0 Participants	0 Participants	—
Number of Participants With a Treatment-emergent Adverse Event Leading to Dose Interruption or Reduction Loncastuximab Tesirine: Dose Interruption	0 Participants	0 Participants	0 Participants	—
Number of Participants With a Treatment-emergent Adverse Event Leading to Dose Interruption or Reduction Loncastuximab Tesirine: Dose Reduction	0 Participants	0 Participants	0 Participants	—
Number of Participants With a Treatment-emergent Adverse Event Leading to Dose Interruption or Reduction Durvalumab: Dose Reduction	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Day 1 to end of treatment (maximum treatment duration at study termination was 336 days)

Population: Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Eastern Cooperative Oncology Group (ECOG) performance status was scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores included the following:

• 0 = fully active, able to carry on all pre-disease performance without restriction
• 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• 2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours
• 3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours
• 4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair
• 5 = dead

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Number of Participants With Changes From Baseline on the Eastern Cooperative Oncology Group (ECOG) Performance Status	2 Participants	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Efficacy analysis set - All participants who received at least one 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 study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

ORR according to the 2014 Lugano classification as determined by the investigator. Overall response rate was the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).

CR was defined as achieving each of the following:

• Complete metabolic response.
• Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).

PR was defined as achieving each of the following:

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

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Overall Response Rate (ORR)	33.3 percentage of participants Interval 0.8 to 90.6	100 percentage of participants Interval 15.8 to 100.0	71.4 percentage of participants Interval 29.0 to 96.3	—

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Efficacy analysis set - All participants who received at least one 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 study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

DOR was defined as the time from the documentation of first tumor response (CR or PR) to disease progression or death.

CR was defined as achieving each of the following:

• Complete metabolic response.
• Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).

PR was defined as achieving each of the following:

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

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Duration of Response (DOR)	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	—

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Efficacy analysis set - All participants who received at least one 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 study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

CRR was defined as the percentage of participants with a BOR of CR, according to the 2014 Lugano classification, as determined by the investigator.

CR was defined as achieving each of the following:

• Complete metabolic response.
• Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Complete Response Rate (CRR)	0 percentage of participants 0 participants had a BOR of CR.	50 percentage of participants Interval 1.3 to 98.7	0 percentage of participants 0 participants had a BOR of CR.	—

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Efficacy analysis set - All participants who received at least one 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 study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

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

CR was defined as achieving each of the following:

• Complete metabolic response.
• Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).

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

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

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Relapse-free Survival (RFS)	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	—

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Efficacy analysis set - All participants who received at least one 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 study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

PFS was defined as the time between start of treatment and the first documentation of progression, or death.

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

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

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Progression-free Survival (PFS)	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	—

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Efficacy analysis set - All participants who received at least one 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 study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

OS was defined as the time between the start of treatment and death from any cause.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Overall Survival (OS)	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	NA months Standard Deviation NA Due to early termination, there was an insufficient number of participants to be able to analyze this endpoint.	—

SECONDARY outcome

Timeframe: Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Population: Pharmacokinetics (PK) population - All participants with at least one pre- Cycle 1 Day 1 (C1D1) and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Cmax of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. Cmax of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - Conjugated Antibody	540 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 52.4	1683 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 22.6	1980 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 30.6	—
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - Total Antibody	1001 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 51.6	3122 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 16.7	2966 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 25.4	—
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - SG3199	—	—	0.0350 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 58.5	—
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Conjugated Antibody	621 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 48.7	1946 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 33.5	1582 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 31.7	—
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Total Antibody	1228 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.6	3510 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 23.9	2899 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 29.3	—

SECONDARY outcome

Timeframe: Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Population: PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

AUC0-last of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. AUC0-last of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - Conjugated Antibody	4265 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 52.5	17217 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 32.7	5763 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 253	—
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - Total Antibody	7603 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 35.0	29456 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 34.3	3682 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 917	—
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - SG3199	—	—	0.00300 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 61.9	—
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Conjugated Antibody	5305 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 24.9	5390 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 1410	7588 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 61.7	—
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Total Antibody	10388 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 21.1	9122 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 1485	13264 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 67.9	—

SECONDARY outcome

Timeframe: Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Population: PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

AUCinf of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. AUCinf of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=2 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - Total Antibody	—	—	15954 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	—
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Conjugated Antibody	5461 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 64.5	18182 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 15.3	8504 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 41.4	—
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Total Antibody	7710 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	27875 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	15382 nanogram days per milliliter (day*ng/mL) Geometric Coefficient of Variation 54.0	—

SECONDARY outcome

Timeframe: Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Population: PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation

Thalf of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. Thalf of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=2 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - Total Antibody	—	—	8.13 day Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	—
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Conjugated Antibody	8.84 day Geometric Coefficient of Variation 33.6	16.9 day Geometric Coefficient of Variation 54.9	5.93 day Geometric Coefficient of Variation 213	—
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Total Antibody	15.1 day Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	33.9 day Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	6.28 day Geometric Coefficient of Variation 180	—

SECONDARY outcome

Timeframe: Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Population: PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

CL for Cycle 2 reflects steady-state clearance. CL of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=2 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - Total Antibody	—	—	0.846 liters per day (L/day) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	—
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Conjugated Antibody	0.927 liters per day (L/day) Geometric Coefficient of Variation 50.7	0.319 liters per day (L/day) Geometric Coefficient of Variation 6.31	1.33 liters per day (L/day) Geometric Coefficient of Variation 36.4	—
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Total Antibody	0.720 liters per day (L/day) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	0.212 liters per day (L/day) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	0.872 liters per day (L/day) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	—

SECONDARY outcome

Timeframe: Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Population: PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Vss of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=2 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 1 - Total Antibody	—	—	9.39 liters (L) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	—
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Conjugated Antibody	11.3 liters (L) Geometric Coefficient of Variation 94.4	7.36 liters (L) Geometric Coefficient of Variation 38.7	6.95 liters (L) Geometric Coefficient of Variation 270	—
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Cycle 2 - Total Antibody	13.7 liters (L) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	8.61 liters (L) Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	5.14 liters (L) Geometric Coefficient of Variation 171	—

SECONDARY outcome

Timeframe: Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Population: PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

AI is the ratio of drug accumulation after repeated administration compared to a single dose. AI of loncastuximab tesirine conjugated antibody and total antibody was calculated from Cycles 1 and 2.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=2 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=2 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody and Total Antibody Cycle 2 - Conjugated Antibody	1.25 ratio Geometric Coefficient of Variation 12.9	1.77 ratio Geometric Coefficient of Variation 33.0	1.27 ratio Geometric Coefficient of Variation 34.4	—
Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody and Total Antibody Cycle 2 - Total Antibody	1.62 ratio Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	2.87 ratio Geometric Coefficient of Variation NA Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.	1.26 ratio Geometric Coefficient of Variation 33.3	—

SECONDARY outcome

Timeframe: Cycle 1 (= 3 weeks): Day 1 pre-dose & Day 15; Cycles 2, 3, 5, 6, & 7 (Cycle 2 = 6 weeks, other cycles = 4 weeks): Day 1 pre-dose; 30 days after last dose of study drugs

Population: Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Detection of ADAs were performed by using a screening assay for identification of antibody positive samples/patients, a confirmation assay, and titer assessment, and were performed using the Meso-Scale Discovery Electrochemiluminescence platform.

Outcome measures

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 Participants Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 Participants Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine	0 Participants	0 Participants	0 Participants	—

Adverse Events

Dose Escalation: Loncastuximab Tesirine 90 μg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Dose Escalation: Loncastuximab Tesirine 120 μg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Dose Escalation: Loncastuximab Tesirine 150 μg/kg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Dose Expansion: Loncastuximab Tesirine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 participants at risk Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 participants at risk Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 participants at risk Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
General disorders Systemic inflammatory response syndrome	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Investigations Blood lactic acid increased	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Renal and urinary disorders Urinary tract obstruction	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years

Other adverse events

Measure	Dose Escalation: Loncastuximab Tesirine 90 μg/kg n=3 participants at risk Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 120 μg/kg n=3 participants at risk Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Escalation: Loncastuximab Tesirine 150 μg/kg n=7 participants at risk Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Dose Expansion: Loncastuximab Tesirine The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	28.6% 2/7 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	28.6% 2/7 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	28.6% 2/7 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	28.6% 2/7 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 10 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Constipation	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Flatulence	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Lip oedema	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 4 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Oedema mouth	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Oral discomfort	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Oral disorder	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
General disorders Asthenia	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	66.7% 2/3 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
General disorders Non-cardiac chest pain	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
General disorders Oedema peripheral	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
General disorders Peripheral swelling	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Infections and infestations Influenza	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	42.9% 3/7 • Number of events 3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Investigations Alanine aminotransferase increased	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	42.9% 3/7 • Number of events 3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	42.9% 3/7 • Number of events 3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	42.9% 3/7 • Number of events 3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Investigations Lymphocyte count decreased	66.7% 2/3 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Nervous system disorders Headache	33.3% 1/3 • Number of events 3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	28.6% 2/7 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Nervous system disorders Taste disorder	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	28.6% 2/7 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 1/3 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 2 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Night sweats	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Vascular disorders Deep vein thrombosis	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Vascular disorders Flushing	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	14.3% 1/7 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Vascular disorders Hot flush	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Vascular disorders Hypertension	0.00% 0/3 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	33.3% 1/3 • Number of events 1 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	0.00% 0/7 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years	— 0/0 • Day 1 up to end of follow-up (maximum duration was 1.5 years) TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years

Additional Information

Clinical Trials Information

ADC Therapeutics SA

Phone: 954-903-7994

Email: clinical.trials@adctherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place