The purpose of this trial is to learn about the safety and effectiveness of the antibody GEN1079 in participants with certain types of cancer. The trial has multiple parts. The first part of the trial tests different doses of GEN1079 to find out if it is safe and determine what are the best doses to use. The second and third parts continue to test the safety of and whether GEN1079 works in additional participants with specific cancer types and at doses chosen based on results from the previous parts of the trial. For each participant, the trial will last approximately 33 to 67 weeks but this may vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 6 to 12 weeks of treatment (the duration of treatment may vary for each participant), and approximately 24 to 52 weeks of follow up after trial treatment ends (the duration of follow up may vary for each participant). During the screening, tumor tissue either collected prior to this trial or freshly collected during screening will be provided by all participants. Participation in the trial will require visits to the site, with more frequent visits at the start of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \[CT\] scans) to monitor whether the treatment is safe and effective. All participants will receive active drug; no one will be given placebo.
This is a first-in-human (FIH), Phase 1, open-label, multinational, dose escalation and expansion trial in participants with advanced selected solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Concentrate for solution.
Yale University
New Haven, Connecticut, United States
RECRUITINGSTART Midwest, LLC
Grand Rapids, Michigan, United States
RECRUITINGSTART New York
Lake Success, New York, United States
RECRUITINGHospital Universitario San Pedro
Logroño, La Rioja, Spain
RECRUITINGHospital Universitario Fundacion Jimenez Diaz
Pozuelo de Alarcón, Madrid, Spain
RECRUITINGClinica Universidad de Navarra
Pamplona, Navarre, Spain
RECRUITINGHospital HM Nou Delfos
Barcelona, Spain
RECRUITINGHospital Quironsalud Barcelona
Barcelona, Spain
RECRUITINGHospital Universitari Vall d'Hebron - VHIO
Barcelona, Spain
RECRUITINGHospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
RECRUITING...and 2 more locations
Part 1 Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: 21 days
Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Adverse Events (AEs)
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Objective Response Rate (ORR)
Time frame: Up to a maximum of approximately 67 months
Part 1 Dose Escalation and Part 2 Dose Refinement: ORR
Time frame: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR)
Time frame: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Duration Of Response (DOR)
Time frame: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR)
Time frame: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Maximum Concentration (Cmax) of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Cmax (Tmax) of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Trough Concentration (Ctrough) of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Sample (AUClast) of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Anti-drug Antibodies (ADA) Against GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: DCR
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: DOR
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: TTR
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Number of Participants with AEs
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Cmax of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Tmax of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Ctrough of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: AUClast of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Number of Participants with ADAs Against GEN1079
Time frame: Up to a maximum of approximately 12 weeks
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