Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors
NCT Number: NCT06573294
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Malignant Solid Tumor|Metastatic Malignant Solid Tumor
Interventions: DRUG: GEN1057
Sponsor: Genmab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2027-10-31

Summary:
The purpose of this trial is to study the antibody GEN1057 when used as a single agent for the treatment of certain types of cancer.

Trial details include:

* The trial duration will be up to approximately 11 months.
* The treatment duration will be up to approximately 4 months (the duration of treatment may vary for each participant) and the follow-up duration will be approximately 6 months.

Participation in the trial will require visits to the site. All participants will receive active drug; no one will be given placebo.

Primary Outcome Measures: Number of Participants With Treatment-emergent Adverse Events (AEs), From first dose until the end of the safety follow-up period (approximately 5 months)|Number of Participants With Dose Limiting Toxicities (DLTs), DLTs will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0., Up to 21 days
Secondary Outcome Measures: Maximum Plasma Concentration (Cmax) of GEN1057, Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)|Time to Reach Cmax (Tmax) of GEN1057, Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)|Trough Concentrations (Ctrough) of GEN1057, Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)|Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUC0-last) of GEN1057, Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)|AUC From Time Zero to Infinity (AUC0-inf) of GEN1057, Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)|Half-life (t1/2) of GEN1057, Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)|Clearance (CL) of GEN1057 From Plasma, Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)|Number of Participants with Anti-drug Antibodies (ADAs) to GEN1057, Serum samples will be screened for ADAs binding to GEN1057 and the titer of confirmed positive samples will be reported., Up to approximately 11 months|Objective Response Rate (ORR), The ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the investigator., Up to approximately 11 months|Duration of Response (DOR), DOR is defined as the time from the first documentation of response (CR or PR) to the date of progressive disease (PD) or death, whichever occurs earlier based on RECIST v1.1 as assessed by the investigator., Up to approximately 11 months|Time to Response (TTR), TTR is defined as the time from Cycle 1 Day 1 (C1D1) to the first documentation of objective response (CR or PR) in participants achieving PR or CR based on RECIST v1.1 as assessed by the investigator., Up to approximately 11 months|Disease Control Rate (DCR), DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD) based on RECIST v1.1 as assessed by the investigator., Up to approximately 11 months