GEN1046 Safety Trial in Patients With Malignant Solid Tumors (NCT03917381)
First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
The goal of this trial is to learn about the antibody acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of patients with certain types of cancer. All subjects will receive active drug; no one will receive placebo. This trial has 2 parts. The purpose of the first part is to find out if acasunlimab at various doses is safe and to find out the best doses of acasunlimab to use. The purpose of the second part is to give acasunlimab to more subjects to see how well the doses of acasunlimab selected in the first part work against cancer when given alone and how well they work when given with pembrolizumab with or without chemotherapy. Trial details include: * The average trial duration for an individual subject will be about 74 weeks. * The average treatment duration for an individual subject will be about 21 weeks. * The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
- Acasunlimab (BIOLOGICAL)
- Acasunlimab in combination with docetaxel (in a single expansion cohort) (BIOLOGICAL)
- Acasunlimab in combination with pembrolizumab (in a separate expansion cohort) (BIOLOGICAL)
- Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts) (BIOLOGICAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (57 Sites)
Showing the first 25 of 57 sites.
- Mayo Clinic — Phoenix, Arizona
- Yale University Cancer Center — New Haven, Connecticut
- Mayo Clinic — Jacksonville, Florida
- Emory University — Atlanta, Georgia
- University of Iowa Hospitals — Iowa City, Iowa
- Norton Healthcare Inc — Louisville, Kentucky
- University of Michigan — Ann Arbor, Michigan
- START Midwest — Grand Rapids, Michigan
- Mayo Clinic — Rochester, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- NYU Langone — New York, New York
- UNC Chapel Hill — Chapel Hill, North Carolina
- Levine Cancer Institute, Atrium Health — Charlotte, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Fakultni nemocnice Brno — Brno,
- University Hospital Brno — Brno,
- Nemocnice AGEL Ostrava-Vítkovice a.s. — Nový Jičín,
- Fakultni nemocnice Olomouc — Olomouc,
- High Technology Hospital Medcenter — Batumi,
- LLC "TIM - Tbilisi Institute of Medicine" — Tbilisi,
- LTD Consilium Medulla — Tbilisi,
- Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd — Tbilisi,
- Onkologiai Klinika — Debrecen,
- BKMK Hospital — Kecskemét,
- Pulmonology Hospital Törökbálinti — Törökbálint,
📞 Contact the Study Coordinator
Phone: (800) 664-4580
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.
More studies in Solid Tumors
- Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors — Basking Ridge, New Jersey
- Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours — Edmonton, Alberta
- Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) — Santa Monica, California
- A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial — Porto Alegre, Rio Grande do Sul
- Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors — Los Angeles, California
- Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors — Phoenix, Arizona
Explore by condition: All Solid Tumors clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.