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

First-in-human, Open-label, Phase 1 Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Select Advanced Malignant Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: GEN1079

Detailed Description

This is a first-in-human (FIH), Phase 1, open-label, multinational, dose escalation and expansion trial in participants with advanced selected solid tumors.

• Study Type: Interventional
• Enrollment (Estimated): 121
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Genmab Trial Information; Phone Number: +4570202728; Email: clinicaltrials@genmab.com

Study Locations

• Spain
  • Barcelona, Spain, 8023
    • Recruiting
    • Hospital Quironsalud Barcelona
  • Barcelona, Spain, 8023
    • Recruiting
    • Hospital HM Nou Delfos
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28050
    • Recruiting
    • Centro Integral Oncologico Clara Campal
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Recruiting
      • Hospital Universitario San Pedro
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Recruiting
      • Hospital Universitario Fundacion Jimenez Diaz
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Clinica Universidad de Navarra
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • START Midwest, LLC
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • START New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: GEN1079 Dose Escalation; Cohorts of participants will receive escalating doses of GEN1079 in up to 5 DLs.	Drug: GEN1079; Concentrate for solution.
Experimental: Part 2: GEN1079 Dose Refinement; Cohorts of participants will receive up to 3 DLs of based on data from the Dose Escalation.	Drug: GEN1079; Concentrate for solution.
Experimental: Part 3: Expansion; Cohorts of participants will receive up to 2 DLs of GEN1079 based on data from Dose Escalation/Dose Refinement.	Drug: GEN1079; Concentrate for solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 1 Dose Escalation and Part 2 Dose Refinement: ORR	Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR)	Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Duration Of Response (DOR)	Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR)	Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Maximum Concentration (Cmax) of GEN1079	Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Cmax (Tmax) of GEN1079	Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Trough Concentration (Ctrough) of GEN1079	Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Sample (AUClast) of GEN1079	Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Anti-drug Antibodies (ADA) Against GEN1079	Up to a maximum of approximately 12 weeks
Part 3 Expansion: DCR	Up to a maximum of approximately 67 weeks
Part 3 Expansion: DOR	Up to a maximum of approximately 67 weeks
Part 3 Expansion: TTR	Up to a maximum of approximately 67 weeks
Part 3 Expansion: Number of Participants with AEs	Up to a maximum of approximately 67 weeks
Part 3 Expansion: Cmax of GEN1079	Up to a maximum of approximately 12 weeks
Part 3 Expansion: Tmax of GEN1079	Up to a maximum of approximately 12 weeks
Part 3 Expansion: Ctrough of GEN1079	Up to a maximum of approximately 12 weeks
Part 3 Expansion: AUClast of GEN1079	Up to a maximum of approximately 12 weeks
Part 3 Expansion: Number of Participants with ADAs Against GEN1079	Up to a maximum of approximately 12 weeks

Collaborators and Investigators

• Sponsor: Genmab
• Investigators: Study Director: Study Official, Genmab

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GCT1079-01; 2025-523931-21 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No