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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07387068
- Acronym / sponsor ID
- GCT1079-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: GEN1079 Dose Escalation | Experimental | Drug: GEN1079Cohorts of participants will receive escalating doses of GEN1079 in up to 5 DLs. |
| Part 2: GEN1079 Dose Refinement | Experimental | Drug: GEN1079Cohorts of participants will receive up to 3 DLs of based on data from the Dose Escalation. |
| Part 3: Expansion | Experimental | Drug: GEN1079Cohorts of participants will receive up to 2 DLs of GEN1079 based on data from Dose Escalation/Dose Refinement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEN1079Concentrate for solution. | Drug | Part 1: GEN1079 Dose Escalation, Part 2: GEN1079 Dose Refinement, Part 3: Expansion |
Primary outcome
Part 1 Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: 21 days
Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Adverse Events (AEs)
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Objective Response Rate (ORR)
Time frame: Up to a maximum of approximately 67 months
18 secondary outcomes
Part 1 Dose Escalation and Part 2 Dose Refinement: ORR
Time frame: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR)
Time frame: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Duration Of Response (DOR)
Time frame: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR)
Time frame: Up to a maximum of approximately 67 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Maximum Concentration (Cmax) of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Cmax (Tmax) of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 1 Dose Escalation and Part 2 Dose Refinement: Trough Concentration (Ctrough) of GEN1079
Time frame: 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
Time frame: 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
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: DCR
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: DOR
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: TTR
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Number of Participants with AEs
Time frame: Up to a maximum of approximately 67 weeks
Part 3 Expansion: Cmax of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Tmax of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Ctrough of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: AUClast of GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Part 3 Expansion: Number of Participants with ADAs Against GEN1079
Time frame: Up to a maximum of approximately 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Official study director
Genmab
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEN1079 in people with Advanced Solid Tumors, run by Genmab at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Genmab Trial Information (+4570202728, clinicaltrials@genmab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs) (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.