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New antibody GEN1079 enters first human tests for advanced cancers

NCT ID NCT07387068

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 121 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    12 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centro Integral Oncologico Clara Campal

    RECRUITING

    Madrid, 28050, Spain

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Hospital HM Nou Delfos

    RECRUITING

    Barcelona, 8023, Spain

  • Hospital Quironsalud Barcelona

    RECRUITING

    Barcelona, 8023, Spain

  • Hospital Universitari Vall d'Hebron - VHIO

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario San Pedro

    RECRUITING

    Logroño, La Rioja, 26006, Spain

  • START Midwest, LLC

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START New York

    RECRUITING

    Lake Success, New York, 11042, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

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