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 for an individual participant will be up to approximately 11 months. * The treatment duration for an individual participant will be up to approximately 4 months (the duration of treatment may vary for each participant) and the follow-up duration for an individual participant 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.
The trial is a first-in-human (FIH) open-label, multicenter, multinational safety trial. The dose escalation will evaluate different dose levels by assessing safety, tolerability, and early efficacy signals to determine the expansion dose(s) of GEN1057 as monotherapy, as well as characterizing the pharmacokinetic (PK) profile and immunogenicity in participants with malignant solid tumors who have metastatic or advanced disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Intravenous (IV) infusion
IV infusion/orally by mouth.
SCRI Oncology Partners
Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
National Cancer Center, Tsukiji 5-1-1
Tokyo, Japan
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Start Madrid Centro Integral Oncologico Clara Campal CIOCC
Madrid, Spain
Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: 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.
Time frame: Up to 21 days
Maximum Plasma Concentration (Cmax) of GEN1057
Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)
Time to Reach Cmax (Tmax) of GEN1057
Time frame: 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
Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)
Half-life (t1/2) of GEN1057
Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)
Clearance (CL) of GEN1057 From Plasma
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 11 months
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