A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma

An AE was defined as any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

Time frame: Up to approximately 1 year 2 months

Population: Measured in the Safety Set, which included participants enrolled and treated with at least 1 dose of GEN3017.

A DLT was defined as any of the following toxicities except those that were clearly due to the underlying disease or extraneous cause: all Grade 5 toxicities, hematological toxicities (Grade 4 neutropenia, Grade 3 and Grade 4 febrile neutropenia lasting \>2 days, Grade 4 thrombocytopenia of any duration with clinically significant bleeding or ≥ Grade 3 thrombocytopenia requiring platelet transfusion, Grade 4 anemia), non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\] per American Society for Transplantation and Cellular Therapy \[ASTCT\] criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, Grade 4 immune effector cell-associated neurotoxicity syndrome \[ICANS\] according to ASTCT criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, tumor lysis syndrome \[TLS\] Grade 4 or Grade 3 unresolved within 5 days, any ≥ Grade 3 \[severe or life-threatening\] non-hematological toxicities \[with exceptions\]).

Time frame: 21 days

Population: Measured in the Dose-Determining Set, which included all participants from the Safety Set who met the minimum exposure criteria and had either completed the DLT observation period or had experienced a DLT during the specified time period.

Venous blood samples were collected for analyzing concentrations of GEN3017.

Time frame: Day 1 and Day 8

Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.

Venous blood samples were collected for analyzing concentrations of GEN3017.

Time frame: Day 1 and Day 8

Population: Measured in the PK Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.

DOR was defined as the time from the first documentation of response (CR or PR) to the date of progressive disease or death, whichever occurred earlier based on the Lugano criteria as assessed by investigator.

Time frame: Up to approximately 1 year 2 months

Population: Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017, in participants who achieved a response. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.

Venous blood samples were collected for analyzing concentrations of GEN3017.

Time frame: Day 1 and Day 8

Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.

Venous blood samples were collected for analyzing concentrations of GEN3017.

Time frame: Day 1 and Day 8

Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.

Venous blood samples were drawn for analysis of ADAs in serum samples.

Time frame: Up to approximately 1 year 2 months

Population: Measured in the Immunogenicity Analysis Set, which included all participants who received at least 1 dose of GEN3017 and had a baseline and at least 1 evaluable on-treatment ADA sample. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.

ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) based on the Lugano criteria as assessed by investigator. All other categories, including not evaluable, were considered non-response. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to \<10 millimeters (mm) in all pathological target and non-target lymph nodes, and normalization of tumor marker level (if applicable). PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Data are presented for the number of participants with ORR.

Time frame: Up to approximately 1 year 2 months

Population: Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.

Venous blood samples were collected for analyzing concentrations of GEN3017.

Time frame: Day 1 and Day 8

Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.

Venous blood samples were collected for analyzing concentrations of GEN3017.

Time frame: Day 1 and Day 8

Population: Measured in the PK Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.

TTR was defined as the time from Day 1 to first documentation of objective response (CR or PR) in participants achieving PR or CR based on the Lugano criteria as assessed by investigator.

Time frame: Up to approximately 1 year 2 months

Population: Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017, in participants who achieved a response. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.

Venous blood samples were collected for analyzing concentrations of GEN3017.

Time frame: Day 1 and Day 8

Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.

Venous blood samples were collected for analyzing concentrations of GEN3017.

Time frame: Day 1 and Day 8

Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.