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GEN1079 for Advanced Solid Tumors

This study is testing a new treatment called GEN1079 for people with advanced solid tumors (cancers that form solid masses). GEN1079 is a type of monoclonal antibody, which is a lab-made protein that can target specific substances in the body, in this case, a protein called RAF. The main goals are to find out if GEN1079 is safe, what the best dose is, and if it can shrink tumors. You might be able to join if you are 18 or older, have certain types of solid cancer that have been confirmed by a biopsy, and have measurable disease. The study is currently recruiting participants.

Study design
This is a Phase 1, open-label study, meaning you and your doctors will know which treatment you are receiving. It aims to enroll 121 participants.
What's involved
The trial will last approximately 33 to 67 weeks for each participant, but this can vary.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects for up to about 67 weeks, and for tumor response for up to about 67 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07387068

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Genmab
~121 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:GEN1079

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs)
Measured over 21 days
+2 more outcomes measured

Conditions

Advanced Solid Tumors

Explore related trials

Solid Neoplasm

NCT07387068

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Centro Integral Oncologico Clara Campal

    Madrid, Spainno site contact published

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, Spainno site contact published

    Recruiting

  • Hospital HM Nou Delfos

    Barcelona, Spainno site contact published

    Recruiting

  • Hospital Quironsalud Barcelona

    Barcelona, Spainno site contact published

    Recruiting

  • Hospital Universitari Vall d'Hebron - VHIO

    Barcelona, Spainno site contact published

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Spainno site contact published

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Pozuelo de Alarcón, Madrid, Spainno site contact published

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spainno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Official · STUDY_DIRECTOR · Genmab

Who to contact

Genmab Trial Information
[email protected]
+4570202728
Email the study team

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Eligibility criteria

Inclusion

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).
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.
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.

Exclusion

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.

What this trial measures

  • Part 1 Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs)21 days
  • Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Adverse Events (AEs)Up to a maximum of approximately 67 weeks
  • Part 3 Expansion: Objective Response Rate (ORR)Up to a maximum of approximately 67 months