🏛️ Verified NIH Record • Updated 2026-08-03

Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors (NCT07387068)

First-in-human, Open-label, Phase 1 Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Select Advanced Malignant Solid Tumors

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Genmab

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Yale University — New Haven, Connecticut

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (12 Sites)

  • Yale University — New Haven, Connecticut
  • START Midwest, LLC — Grand Rapids, Michigan
  • START New York — Lake Success, New York
  • Hospital Universitario San Pedro — Logroño, La Rioja
  • Hospital Universitario Fundacion Jimenez Diaz — Pozuelo de Alarcón, Madrid
  • Clinica Universidad de Navarra — Pamplona, Navarre
  • Hospital HM Nou Delfos — Barcelona,
  • Hospital Quironsalud Barcelona — Barcelona,
  • Hospital Universitari Vall d'Hebron - VHIO — Barcelona,
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid,
  • Hospital Universitario 12 de Octubre — Madrid,
  • Centro Integral Oncologico Clara Campal — Madrid,

📞 Contact the Study Coordinator

Phone: (457) 020-2728

Email: clinicaltrials@genmab.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗