New antibody GEN1079 enters first human tests for advanced cancers
NCT ID NCT07387068
First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 7 times
Summary
This early-stage trial is testing a new antibody called GEN1079 in people with certain advanced solid tumors. The study has three parts: first, finding a safe dose; then refining the dose; and finally, checking if the drug shrinks tumors. About 121 participants will receive the active drug, and the study lasts up to 67 weeks per person.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GEN1079 (an antibody)
- What this could lead to
- If this trial succeeds, it could point toward a new treatment option for certain advanced solid tumors.
- What could go wrong
- This is a very early Phase 1 trial, so the drug may not be safe or effective. It is small and only tests safety and dosing, not a proven treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 121 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: All Parts: * Must have histologically confirmed selected solid cancers. * Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion(s) must be outside the field of prior radiation therapy unless there is documented progression in the lesion(s). * Must provide formalin-fixed paraffin-embedded tumor tissue (aspirates and bone specimens are not acceptable), archival or fresh, collected after discontinuation of their most recent anticancer treatment and prior to the first administration of GEN1079. If an archival specimen is unavailable, a procedure for obtaining a fresh tumor biopsy must be performed, provided it is performed according to standard of care and is deemed safe by the investigator. * Has acceptable laboratory test results prior to trial treatment administration, including platelet count \>150×10\^9/litre (L). Parts 1 and 2: * Have histologically confirmed selected solid cancers that are metastatic or unresectable. * Prior protocol defined therapy is permitted, with no restrictions on the number of prior lines of therapy received or the time since the most recent therapy. Part 3: * Have histologically confirmed selected solid cancer that is metastatic or unresectable. * Must have received a defined number of prior lines of a protocol defined regimen. Key Exclusion Criteria: * Has intercurrent illness or known history of any of the following that could affect compliance with the protocol or interpretation of the results, including but not limited to: * Autoimmune diseases, eg, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), neuromyelitis optica (NMO), myasthenia gravis (MG), cold agglutinin disease (CAD), atypical hemolytic uremic syndrome (aHUS), immunoglobulin A (IgA) nephropathy, inflammatory bowel disease (IBD; Crohn's and ulcerative colitis). * Grade ≥3 allergic reactions to prior monoclonal antibody therapy. * Known history of interstitial lung disease (ILD) Grade ≥3 or prior or ongoing noninfectious pneumonitis with evidence of progressive fibrotic changes on baseline imaging, unless clinically and radiologically stable for ≥6 months with preserved pulmonary function (eg, diffusing capacity of the lungs for carbon monoxide \[DLCO\] ≥ 50% predicted). * Disorders associated with platelet function defects, decreased number of platelets (eg, splenomegaly, chronic liver disease or bleeding disorders such as hemophilia or Von Willebrand disease), or a known history or high risk of bleeding events requiring transfusions or hospitalizations. * Treatment with any plasma-based therapy within 7 days prior to Cycle 1 Day 1. * Any history of intracerebral arteriovenous malformation (shunts), cerebral aneurysm, spinal cord compression (from disease), carcinomatous meningitis, or stroke. Note: Transient ischemic attack \>1 month prior to screening is allowed. * Participants who, in the event of a medical complication during the trial treatment period, would be unable to temporarily discontinue and restart anticoagulant/antiplatelet therapy using appropriate bridging strategies (eg, low molecular weight heparin) in alignment with local standard of care. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centro Integral Oncologico Clara Campal
RECRUITINGMadrid, 28050, Spain
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Clinica Universidad de Navarra
RECRUITINGPamplona, Navarre, 31008, Spain
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Hospital HM Nou Delfos
RECRUITINGBarcelona, 8023, Spain
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Hospital Quironsalud Barcelona
RECRUITINGBarcelona, 8023, Spain
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Hospital Universitari Vall d'Hebron - VHIO
RECRUITINGBarcelona, 8035, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario Fundacion Jimenez Diaz
RECRUITINGPozuelo de Alarcón, Madrid, 28223, Spain
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Hospital Universitario Fundacion Jimenez Diaz
RECRUITINGMadrid, 28040, Spain
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Hospital Universitario San Pedro
RECRUITINGLogroño, La Rioja, 26006, Spain
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START Midwest, LLC
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START New York
RECRUITINGLake Success, New York, 11042, United States
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Yale University
RECRUITINGNew Haven, Connecticut, 06520, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors