Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors
Start Date
4/7/2026
Completion Date
1/1/2031
Summary
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.
Detailed Description
This is a first-in-human (FIH), Phase 1, open-label, multinational, dose escalation and expansion trial in participants with advanced selected solid tumors.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
GEN1079
Conditions
Locations
Yale University
New Haven, Connecticut 06520
United States
START Midwest, LLC
Grand Rapids, Michigan 49546
United States
START New York
Lake Success, New York 11042
United States
Hospital Universitario San Pedro
Logroño, La Rioja 26006
Spain
Hospital Universitario Fundacion Jimenez Diaz
Pozuelo de Alarcón, Madrid 28223
Spain
Clinica Universidad de Navarra
Pamplona, Navarre 31008
Spain
Hospital HM Nou Delfos
Barcelona, 8023
Spain
Hospital Quironsalud Barcelona
Barcelona, 8023
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Centro Integral Oncologico Clara Campal
Madrid, 28050
Spain