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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002670-43 | EudraCT Number |
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In a limited number of patients, no additional activity was evident for the combination vs. loncastuximab tesirine monotherapy.
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The purpose of this phase 1 study is to evaluate the safety and anti-tumor activity of Loncastuximab Tesirine (ADCT-402) and Durvalumab in participants with Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
This is a Phase 1b, open-label, single-arm combination study with a dose escalation phase (Part 1) followed by a dose expansion phase (Part 2). The study will enroll approximately 75 participants.
A standard 3+3 dose escalation design will be used for Part 1. The DLT period will be the 21 days after the first durvalumab dose.
Part 2 will consist of up to 3 expansion cohorts, one for DLBCL, one for MCL, and one for FL. Each cohort will be approximately 20 participants treated at the dose determined in Part 1.
The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3, 6, and 4 weeks), and a Follow-up Period (approximately every 12 week visits for up to 2 years after treatment discontinuation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADCT-402 | Experimental | Dose escalation phase: Ascending doses of Loncastuximab tesirine will be administered using a traditional 3+3 design. Dose level 1: 90 µg/kg, every 3 weeks (Q3W). Dose level 2: 120 µg/kg, Q3W. Dose level 3: 150 µg/kg, Q3W. Loncastuximab tesirine will be given for 2 doses, 3 weeks apart. Dose expansion phase: Loncastuximab tesirine will be administered at the recommended dose determined in the dose escalation phase. Durvalumab will also be administered at a dose of 1500 mg once every 4 weeks (Q4W) throughout the dose escalation phase and dose expansion phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loncastuximab Tesirine and Durvalumab | Drug | intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 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:
Clinically significant changes from baseline for safety laboratory values, vital sign measurements and electrocardiograms (ECGs) were recorded as TEAEs. | Day 1 to 30 days after the last dose of study drugs (maximum treatment duration at study termination was 336 days) |
| Number of Participants With a Dose-limiting Toxicity | 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. | 21 days after first dose of durvalumab (Day 8 to Day 29) |
| Number of Participants With a Treatment-emergent Adverse Event Leading to Dose Interruption or Reduction | Day 1 to end of treatment (maximum treatment duration at study termination was 336 days) | |
| Number of Participants With Changes From Baseline on the Eastern Cooperative Oncology Group (ECOG) Performance Status | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 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:
PR was defined as achieving each of the following:
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Inclusion Criteria:
Male or female participants aged 18 years or older
Pathologic diagnosis of DLBCL, MCL, or FL
Participants must have relapsed or refractory disease and have failed or been intolerant to standard therapy
Participants who have received previous CD19-directed therapy must have a biopsy that shows CD19 expression after completion of the CD19-directed therapy
Measurable disease as defined by the 2014 Lugano Classification
Participants must be willing to undergo tumor biopsy
ECOG performance status 0-1
Screening laboratory values within the following parameters:
Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 3 days prior to start of study drug on C1D1 for women of childbearing potential
Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of study therapy
Exclusion Criteria:
Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody.
Previous therapy with any checkpoint inhibitor
Autologous stem cell transplant within 100 days prior to start of study drug (C1D1)
History of allogenic stem cell transplant
History of solid organ transplant
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice)
Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV)
History of Stevens-Johnson syndrome or toxic epidermal necrolysis
Lymphoma with active central nervous system (CNS) involvement at the time of screening, including leptomeningeal disease
Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
Breastfeeding or pregnant
Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease
Radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor.
Major surgery within 28 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor. Note: Local surgery of isolated lesions for palliative intent is acceptable.
Use of any other experimental medication within 14 days prior to start of study drug (C1D1)
Planned live vaccine administration after starting study drug (C1D1)
Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening.
Congenital long QT syndrome or a corrected QTcF interval of >470 ms at screening (unless secondary to pacemaker or bundle branch block)
History of another primary malignancy except for:
History of active primary immunodeficiency or any other significant medical illness, abnormality, or condition that would, in the Investigator's judgement, make the patient inappropriate for study participation or put the participant at risk.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| UCH-MHS Memorial Hospital Centeral |
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16 participants had signed informed consent, however 3 were considered screen failures. The remaining 13 participants were enrolled and received study treatment.
13 participants were enrolled at 5 sites in the United States and 3 sites in Spain between February 2019 and October 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2019 | Aug 10, 2021 |
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| Day 1 to end of treatment (maximum treatment duration at study termination was 336 days) |
| Up to 1.5 years |
| Duration of Response (DOR) | 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:
PR was defined as achieving each of the following:
| Up to 1.5 years |
| Complete Response Rate (CRR) | 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:
| Up to 1.5 years |
| Relapse-free Survival (RFS) | 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:
Disease progression was defined as progressive metabolic disease and one of the following:
| Up to 1.5 years |
| Progression-free Survival (PFS) | 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:
| Up to 1.5 years |
| Overall Survival (OS) | OS was defined as the time between the start of treatment and death from any cause. | Up to 1.5 years |
| Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | 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. | 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 |
| 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 | 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. | 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 |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | 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. | 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 |
| Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | 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. | 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 |
| Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | CL for Cycle 2 reflects steady-state clearance. CL of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. | 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 |
| Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | Vss of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. | 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 |
| Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody and Total Antibody | 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. | 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 |
| Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine | 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. | 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 |
| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| University of Florida Health Shands Cancer Hospital | Gainesville | Florida | 32603 | United States |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Icahm School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| Baylor Scott & White Medical Center - Temple | Temple | Texas | 76508 | United States |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Marañon Pabellón de Oncología | Madrid | 28009 | Spain |
| Hospital Universitario Fundación Jiménez Díaz Unidad de Limfomas Servicio de Hematologia | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Macarena Servicio Oncologia Medica | Seville | 41009 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41015 | Spain |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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|
Safety analysis set - All participants who received the study drug. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated, therefore data is only available for the dose escalation.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 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:
Clinically significant changes from baseline for safety laboratory values, vital sign measurements and electrocardiograms (ECGs) were recorded as TEAEs. | 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. | Posted | Count of Participants | Participants | Day 1 to 30 days after the last dose of study drugs (maximum treatment duration at study termination was 336 days) |
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| Primary | Number of Participants With a Dose-limiting Toxicity | 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. | 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. | Posted | Count of Participants | Participants | 21 days after first dose of durvalumab (Day 8 to Day 29) |
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| Primary | Number of Participants With a Treatment-emergent Adverse Event Leading to Dose Interruption or Reduction | 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. | Posted | Count of Participants | Participants | Day 1 to end of treatment (maximum treatment duration at study termination was 336 days) |
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| Primary | Number of Participants With Changes From Baseline on the Eastern Cooperative Oncology Group (ECOG) Performance Status | 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:
| 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. | Posted | Count of Participants | Participants | Day 1 to end of treatment (maximum treatment duration at study termination was 336 days) |
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| Secondary | Overall Response Rate (ORR) | 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:
PR was defined as achieving each of the following:
| 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.5 years |
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| Secondary | Duration of Response (DOR) | 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:
PR was defined as achieving each of the following:
| 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. | Posted | Mean | Standard Deviation | months | Up to 1.5 years |
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| Secondary | Complete Response Rate (CRR) | 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:
| 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.5 years |
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| Secondary | Relapse-free Survival (RFS) | 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:
Disease progression was defined as progressive metabolic disease and one of the following:
| 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. | Posted | Mean | Standard Deviation | months | Up to 1.5 years |
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| Secondary | Progression-free Survival (PFS) | 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:
| 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. | Posted | Mean | Standard Deviation | months | Up to 1.5 years |
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| Secondary | Overall Survival (OS) | OS was defined as the time between the start of treatment and death from any cause. | 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. | Posted | Mean | Standard Deviation | months | Up to 1.5 years |
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| Secondary | Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram days per milliliter (day*ng/mL) | 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 |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram days per milliliter (day*ng/mL) | 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | 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. | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | day | 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | CL for Cycle 2 reflects steady-state clearance. CL of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per day (L/day) | 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 | Vss of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters (L) | 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody and Total Antibody | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine | 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. | 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. | Posted | Count of Participants | Participants | 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 |
|
Day 1 up to end of follow-up (maximum duration was 1.5 years)
TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG001 | 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. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG002 | 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. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema mouth | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information | ADC Therapeutics SA | 954-903-7994 | clinical.trials@adctherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2020 | Aug 10, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000710749 | loncastuximab tesirine |
| C000613593 | durvalumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| CTCAE Grade ≥3 TEAE |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
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