Actively Recruiting
Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors
Led by Genmab · Updated on 2026-05-05
121
Participants Needed
7
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have histologically confirmed selected solid cancers.
- Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with lesions outside prior radiation areas unless progressed.
- Must provide formalin-fixed paraffin-embedded tumor tissue, archival or fresh, collected after last anticancer treatment and before GEN1079 administration.
- Have acceptable lab results including platelet count >150×10^9/litre.
- For Parts 1 and 2: cancer must be metastatic or unresectable.
- Prior protocol defined therapy allowed with no limits on number or timing.
- For Part 3: must have metastatic or unresectable cancer and received defined prior protocol therapies.
You will not qualify if you...
- Have autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, neuromyelitis optica, myasthenia gravis, cold agglutinin disease, atypical hemolytic uremic syndrome, IgA nephropathy, or inflammatory bowel disease.
- History of Grade ≥3 allergic reactions to monoclonal antibody therapy.
- Known interstitial lung disease Grade ≥3 or ongoing pneumonitis with fibrotic changes unless stable for ≥6 months and preserved lung function.
- Disorders causing platelet defects or bleeding risks requiring transfusions or hospitalizations.
- Received plasma-based therapy within 7 days before starting trial treatment.
- History of intracerebral arteriovenous malformation, cerebral aneurysm, spinal cord compression, carcinomatous meningitis, or stroke (transient ischemic attack >1 month prior allowed).
- Unable to temporarily stop and restart anticoagulant or antiplatelet therapy if needed during trial treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
2
START New York
Lake Success, New York, United States, 11042
Actively Recruiting
3
Hospital Universitario San Pedro
Logroño, La Rioja, Spain, 26006
Actively Recruiting
4
Hospital Universitario Fundacion Jimenez Diaz
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
5
Hospital Quironsalud Barcelona
Barcelona, Spain, 8023
Actively Recruiting
6
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
7
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Actively Recruiting
Research Team
G
Genmab Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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