Advanced Solid TumorsPhase 1NCT07387068
Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors
A Phase 1 study testing GEN1079 in people with Advanced Solid Tumors, run by Genmab at 12 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GEN1079
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 7 Apr 2026to Jan 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
Spain9 sites, 9 recruiting
- Recruiting
Hospital HM Nou Delfos
Barcelona, 8023
- Recruiting
Hospital Quironsalud Barcelona
Barcelona, 8023
- Recruiting
Hospital Universitari Vall d'Hebron - VHIO
Barcelona, 8035
- Recruiting
Hospital Universitario San Pedro
Logroño, La Rioja, 26006
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Centro Integral Oncologico Clara Campal
Madrid, 28050
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Pozuelo de Alarcón, Madrid, 28223
United States3 sites, 3 recruiting
- Recruiting
START Midwest, LLC
Grand Rapids, Michigan, 49546
- Recruiting
START New York
Lake Success, New York, 11042
- Recruiting
Yale University
New Haven, Connecticut, 06520
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- GEN1079
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN1079Drug
Concentrate for solution.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: GEN1079 Dose Escalation | Experimental | Cohorts of participants will receive escalating doses of GEN1079 in up to 5 DLs. Receives: Drug: GEN1079 |
| Part 2: GEN1079 Dose Refinement | Experimental | Cohorts of participants will receive up to 3 DLs of based on data from the Dose Escalation. Receives: Drug: GEN1079 |
| Part 3: Expansion | Experimental | Cohorts of participants will receive up to 2 DLs of GEN1079 based on data from Dose Escalation/Dose Refinement. Receives: Drug: GEN1079 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs)
Measured: 21 days
Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Adverse Events (AEs)
Measured: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Objective Response Rate (ORR)
Measured: Up to a maximum of approximately 67 months
Secondary outcomes (18)
Part 1 Dose Escalation and Part 2 Dose Refinement: ORR
Measured: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR)
Measured: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Duration Of Response (DOR)
Measured: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR)
Measured: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Maximum Concentration (Cmax) of GEN1079
Measured: Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Cmax (Tmax) of GEN1079
Measured: Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Trough Concentration (Ctrough) of GEN1079
Measured: 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
Measured: 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
Measured: Up to a maximum of approximately 12 weeks
Part 3 Expansion: DCR
Measured: Up to a maximum of approximately 67 weeks
Part 3 Expansion: DOR
Measured: Up to a maximum of approximately 67 weeks
Part 3 Expansion: TTR
Measured: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Number of Participants with AEs
Measured: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Cmax of GEN1079
Measured: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Tmax of GEN1079
Measured: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Ctrough of GEN1079
Measured: Up to a maximum of approximately 12 weeks
Part 3 Expansion: AUClast of GEN1079
Measured: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Number of Participants with ADAs Against GEN1079
Measured: Up to a maximum of approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start7 Apr 2026
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387068
- Sponsor's protocol ID
- GCT1079-01
- Other IDs
- 2025-523931-21, 2025
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No