Solid TumoursPhase 1NCT07695831
A Phase 1 Trial of GEN1119 in Participants With Solid Tumors
A Phase 1 study testing GEN1119 in people with Solid Tumours, run by Genmab at 8 sites in 3 countries.
Trial summary
The purpose of this trial is to learn about the safety and efficacy of GEN1119 when it is used for the treatment of participants with certain types of cancer. The trial has multiple parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- GEN1119
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 13 Aug 2026to Jun 2029
- 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
- Have histologically or cytologically confirmed diagnosis of protocol-specified solid tumours.
- Have progressed on standard of care (SoC) therapy applicable for the tumor type, or for whom there is no available SoC therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1119 may be a suitable option in the opinion of the investigator.
- Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Have acceptable laboratory test results before GEN1119 administration per protocol
Who cannot join
- Prior treatment with certain protocol-defined therapy.
- Prior treatment with T-cell engagers, chimeric antigen receptor T-cell (CAR-T-cell) therapies, other protocol defined therapies, or other therapeutic moieties targeting certain protocol-defined molecules.
- Treatment with an anticancer agent within 4 weeks or within 5 half lives of the drug, whichever is shorter, but not within 2 weeks before Cycle 1 Day 1 (C1D1).
- Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or lower, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ Grade 2. There is no limitation for alopecia from previous therapies.
- Participant should not have active Hepatitis B infection. Participants with prior infections or chronic infections are allowed if monitored or treated as per local SOC and are negative for hepatitis B virus (HBV) DNA measured viral load.
- Hepatitis C virus (HCV): Known active HCV infection (defined as positive for HCV ribonucleic acid [RNA] [qualitative]).
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
Spain4 sites, 4 recruiting
- Recruiting
START - Hospital HM Nou Delfos
Barcelona, Catalonia, 08023
- Recruiting
START Rioja - Hospital Universitario San Pedro
Logroño, La Rioja, 26006
- Recruiting
START Madrid - Hospital Universitario Fundacion Jimenez Díaz
Madrid, 28040
- Recruiting
START Madrid- CIOCC. Hospital HM Sanchinarro
Madrid, 28050
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
- Recruiting
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, 135-8550
France1 site, 1 recruiting
- Recruiting
Centre Eugene Marquis
Rennes, Ille Et Vilaine, 35042
About this study
Official title: First-In-Human, Open-Label Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GEN1119 in Participants With Solid Tumors
The purpose of this trial is to learn about the safety and efficacy of GEN1119 when it is used for the treatment of participants with certain types of cancer.
The trial has multiple parts. The first part of the trial will test different doses of GEN1119 to find out if it is safe and to determine what are the best doses to use. The second part will further refine this optimal dose. The third part continues to test the safety and how well GEN1119 works in additional participants with specific cancer types and at doses chosen based on the results of the first 2 parts of the trial.
Read more
For each participant, the trial will last approximately 18 months but this may vary for each individual. This includes a Screening Period of up to 21 days before receiving trial treatment, an estimated 5 months of treatment (the duration of treatment may vary for each participant), and approximately 12.5 months of follow up after trial treatment ends (the duration of follow up may vary for each participant).
Participation in the trial will require visits to the site, with more frequent visits during the first 6 weeks 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, multicenter, multinational trial in participants with certain types of solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of GEN1119.
- Conditions
- Solid Tumours
- Being tested
- GEN1119
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN1119Drug
Administered at certain DLs on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (Part 1): GEN1119 | Experimental | Participants will receive a number of dose levels (DLs) of GEN1119. Receives: Drug: GEN1119 |
| Dose Refinement (Part 2): GEN1119 | Experimental | Participants will be randomized to receive a number of DLs of GEN1119. Receives: Drug: GEN1119 |
| Expansion (Part 3): GEN1119 | Experimental | Participants with certain solid tumours will receive GEN1119 at the recommended expansion dose(s) as defined in Parts 1 and/or 2. Receives: Drug: GEN1119 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Dose-limiting Toxicities (DLTs)
Measured: 21 days
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
Measured: Up to approximately 17.5 months
Part 3: Objective Response Rate (ORR)
Measured: Up to approximately 17.5 months
Secondary outcomes (7)
Part 1, Part 2 and Part 3: Plasma Concentration of GEN1119-related Analytes
Measured: Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Number of Participants with Anti-drug Antibodies (ADAs) Against GEN1119
Measured: Up to approximately 17.5 months
Part 1 and Part 2: ORR
Measured: Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Duration of Response (DOR)
Measured: Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Disease Control Rate (DCR)
Measured: Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Time to Response (TTR)
Measured: Up to approximately 17.5 months
Part 3: Number of Participants with AEs
Measured: Up to approximately 17.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start13 Aug 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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
- 112 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
- NCT07695831
- Sponsor's protocol ID
- GCT1119-01
- Other IDs
- 2026-525610-62
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Human, Open-Label Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GEN1119 in Participants With Solid Tumors
- ClinicalTrials.gov ID
- NCT07695831
- Acronym / sponsor ID
- GCT1119-01
- Conditions
- Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 10 Jul 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 efficacy of GEN1119 when it is used for the treatment of participants with certain types of cancer.
The trial has multiple parts. The first part of the trial will test different doses of GEN1119 to find out if it is safe and to determine what are the best doses to use. The second part will further refine this optimal dose. The third part continues to test the safety and how well GEN1119 works in additional participants with specific cancer types and at doses chosen based on the results of the first 2 parts of the trial.
For each participant, the trial will last approximately 18 months but this may vary for each individual. This includes a Screening Period of up to 21 days before receiving trial treatment, an estimated 5 months of treatment (the duration of treatment may vary for each participant), and approximately 12.5 months of follow up after trial treatment ends (the duration of follow up may vary for each participant).
Participation in the trial will require visits to the site, with more frequent visits during the first 6 weeks 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, multicenter, multinational trial in participants with certain types of solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of GEN1119.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Part 1): GEN1119 | Experimental | Drug: GEN1119Participants will receive a number of dose levels (DLs) of GEN1119. |
| Dose Refinement (Part 2): GEN1119 | Experimental | Drug: GEN1119Participants will be randomized to receive a number of DLs of GEN1119. |
| Expansion (Part 3): GEN1119 | Experimental | Drug: GEN1119Participants with certain solid tumours will receive GEN1119 at the recommended expansion dose(s) as defined in Parts 1 and/or 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have histologically or cytologically confirmed diagnosis of protocol-specified solid tumours.
- Have progressed on standard of care (SoC) therapy applicable for the tumor type, or for whom there is no available SoC therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1119 may be a suitable option in the opinion of the investigator.
- Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Have acceptable laboratory test results before GEN1119 administration per protocol
Key exclusion criteria (7 listed)
- Prior treatment with certain protocol-defined therapy.
- Prior treatment with T-cell engagers, chimeric antigen receptor T-cell (CAR-T-cell) therapies, other protocol defined therapies, or other therapeutic moieties targeting certain protocol-defined molecules.
- Treatment with an anticancer agent within 4 weeks or within 5 half lives of the drug, whichever is shorter, but not within 2 weeks before Cycle 1 Day 1 (C1D1).
- Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or lower, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ Grade 2. There is no limitation for alopecia from previous therapies.
- Participant should not have active Hepatitis B infection. Participants with prior infections or chronic infections are allowed if monitored or treated as per local SOC and are negative for hepatitis B virus (HBV) DNA measured viral load.
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 |
|---|---|---|
| GEN1119Administered at certain DLs on specified days. | Drug | Dose Escalation (Part 1): GEN1119, Dose Refinement (Part 2): GEN1119, Expansion (Part 3): GEN1119 |
Primary outcome
Part 1: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: 21 days
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 17.5 months
Part 3: Objective Response Rate (ORR)
Time frame: Up to approximately 17.5 months
7 secondary outcomes
Part 1, Part 2 and Part 3: Plasma Concentration of GEN1119-related Analytes
Time frame: Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Number of Participants with Anti-drug Antibodies (ADAs) Against GEN1119
Time frame: Up to approximately 17.5 months
Part 1 and Part 2: ORR
Time frame: Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Duration of Response (DOR)
Time frame: Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Disease Control Rate (DCR)
Time frame: Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Time to Response (TTR)
Time frame: Up to approximately 17.5 months
Part 3: Number of Participants with AEs
Time frame: Up to approximately 17.5 months
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 6 Oct 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
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEN1119 in people with Solid Tumours, run by Genmab at 8 sites in 3 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 4 inclusion and 7 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Japan, France. 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: 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 6 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.