Trial Outcomes & Findings for GEN1046 Safety Trial in Patients With Malignant Solid Tumors (NCT NCT03917381)

This trial is ongoing. These primary analysis results only are reported. Final analysis results will be reported after the end of trial.

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

In this trial, a DLT was defined as any grade 5 toxicity, grade 4 neutropenia lasting more than 7 days, grade 3 and 4 febrile neutropenia, grade 4 thrombocytopenia for minimal duration of 7 days, grade 3\&4 hemorrhage associated with thrombocytopenia of ≥ grade 3 requiring platelet transfusion, grade 4 anemia, liver toxicity (transaminases and bilirubin elevations), grade 3 nausea that didn't respond to optimal antiemetic treatment within 7 days, grade ≥3 vomiting that didn't respond to optimal antiemetic treatment within 3 days, grade ≥3 diarrhea that didn't respond to optimal antidiarrheal treatment within 3 days, grade 3 immune-related adverse event (irAEs) that didn't improve to ≤ grade 1 within 7 days by appropriate care or with corticosteroids (with exceptions per protocol), any grade 4 irAE, any other ≥ grade 3 non-hematological adverse events (AE), which occurred during the first GEN1046 treatment cycle (with exceptions per protocol).

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. Treatment-emergent AEs were any AEs that developed or worsened after the first dose of a medicinal product. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on response evaluation criteria in solid tumors (RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have had a reduction in short axis to \<10 millimeters (mm). PR was defined as ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.

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. Treatment-emergent AEs were any AEs that developed or worsened after the first dose of a medicinal product. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Venous blood samples were collected for measurement of plasma concentrations of GEN1046. Data reported are average values for Cycle 1 and Cycle 2.

Venous blood samples were collected for measurement of plasma concentrations of GEN1046. Data reported are average values for Cycle 1 and Cycle 2.

Venous blood samples were collected for measurement of serum concentrations of ADAs. A participant was considered as positive overall status if: (i) negative at baseline and at least one positive post-baseline result; or (ii) positive at baseline and at least one positive post-baseline result with a titer higher than baseline.

ORR was defined as the percentage of participants with BOR of CR or PR based on RECIST. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have had a reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of LDs.

DCR was defined as the percentage of participants with confirmed BOR of CR, PR, or stable disease (SD) according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have had a reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of LDs. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Follow-up measurements must have met the SD criteria at least once and for a minimum time period of 6 weeks (±7 days) after first treatment.

DOR was defined as the time from first documentation of response (CR or PR) to the date of the first documented progression or death whichever occurred earlier based on RECIST v1.1. DOR only applied to participants whose confirmed best overall response was CR or PR (i.e., responders).

PFS was defined as the time from Day 1 in Cycle 1 (cycles were 21 days) to the first documented progression or death due to any cause, whichever occurred first based on RECIST version 1.1.

OS was defined as the time from Day 1 in Cycle 1 (cycles were 21 days) to death due to any cause.