Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT07387068
- Run by
- Genmab
- People needed
- 121
- Starts
- 2026-04-07
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Yale University — New Haven, Connecticut, United States (enrolling)
- START Midwest, LLC — Grand Rapids, Michigan, United States (enrolling)
- START New York — Lake Success, New York, United States (enrolling)
- Hospital Universitario San Pedro — Logroño, La Rioja, Spain (enrolling)
- Hospital Universitario Fundacion Jimenez Diaz — Pozuelo de Alarcón, Madrid, Spain (enrolling)
- Clinica Universidad de Navarra — Pamplona, Navarre, Spain (enrolling)
- Hospital HM Nou Delfos — Barcelona, Spain (enrolling)
- Hospital Quironsalud Barcelona — Barcelona, Spain (enrolling)
- Hospital Universitari Vall d'Hebron - VHIO — Barcelona, Spain (enrolling)
- Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- Centro Integral Oncologico Clara Campal — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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