The main purpose of this first-in-human study of GEN1056, is to evaluate safety. In addition, the study will determine the recommended dose and frequency for subsequent clinical studies and will assess the preliminary anti-tumor activity of GEN1056. GEN1056 will be studied in patients with advanced or metastatic solid cancer, for whom standard of care (SOC) therapy is not an option. All participants will get GEN1056.
The trial is a first-in-human open-label, dose-finding, multinational safety trial, in participants with advanced or metastatic solid (non central nervous system \[CNS\]) tumors that have exhausted SOC therapy or are not candidates for SOC therapy, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1056. The trial will be conducted as follows: * The Dose Escalation part (Part 1) will explore the safety of escalating doses of GEN1056 * The Dose schedule optimization part (Part 2) will explore further safety and tolerability in an alternate schedule of a dose based on data outcome available from Part 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
GEN1056 will be administered as an intravenous (IV) infusion. The dose levels will be determined by the starting dose and the escalation steps taken in the trial in Part 1. In Part 2, the dose and schedule will be decided based on data outcome from Part 1.
ARENSIA Exploratory Medicine LLC
Tbilisi, Georgia
ARENSIA Exploratory Medicine Phase I Unit
Chisinau, Moldova
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
Dose Limiting Toxicity (DLT)
To define the maximum tolerated dose (MTD) and/or recommended phase 2 dose(s) (RP2D) of GEN1056
Time frame: DLTs are evaluated during the first 21 days after a patient's first dose
Incidence and severity of adverse events (AEs)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Number of participants with clinical significant shifts from baseline in clinical laboratory parameters
Clinical laboratory parameters assessed: Hematology, biochemistry, coagulation, TSH, T3 and T4, urinalysis
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Objective response rate (ORR)
Anti-tumor activity of GEN1056 as monotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for responders (with confirmation)
Time frame: From first infusion of trial drug to the last evaluable imaging assessment (an estimated average of 7 months)
Duration of response (DOR)
Anti-tumor activity of GEN1056 as monotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for responders (with confirmation)
Time frame: From initial onset of response to first progression event (defined as radiographic progression or death; an estimated average of 7 months)
Progression-free survival (PFS)
Anti-tumor activity of GEN1056 as monotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: From first infusion of trial drug to first progression event (defined as radiographic progression or death; an estimated average of 7 months)
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Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
MD Anderson Cancer Centre
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Overall survival (OS)
Defined as time of death, due to any cause
Time frame: From first infusion of trial drug to death due to any cause, or to last contact date in case of no observed death (assessed up to 2 years after the last participant's first dose in the trial)
Rate at which the drug is removed from the body (clearance)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Amount of drug in the body (volume of distribution)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Area under the concentration time curve (AUC) from time zero to last quantifiable sample AUClast
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Maximum (peak) observed serum drug concentration (Cmax)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Time to reach maximum (peak) serum drug concentration (Tmax) after dosing
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Time after dosing at which the lowest drug concentration is observed before the next dose is administered, predose trough concentration (Ctrough)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Elimination half-life (T1/2) of the drug
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Incidence of anti-drug antibodies (anti GEN1056 antibodies)
Characterize the immunogenicity of GEN1056
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)