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Solid TumorsPhase 1NCT07416123

A Study of GEN1106 in Participants With Solid Tumors

A Phase 1 study testing GEN1106 in people with Solid Tumors and Urothelial Carcinoma, run by Genmab at 10 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this trial is to learn about the safety and effectiveness of GEN1106 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 Tumors, Urothelial Carcinoma
What is being tested?
GEN1106
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
10 sitesin 3 countries
Study dates
14 Apr 2026to 25 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 received and progressed on, been intolerant to, or be ineligible for all available standard of care (SoC) therapies known to provide a survival and/or quality of life benefit for their tumor type. These therapies should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, enfortumab vedotin (EV), and other therapies, where applicable.
  • Have measurable disease according to RECIST v1.1.
  • Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.
  • Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.
  • Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).

Who cannot join

  • Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.
  • Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.
  • Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2.
  • Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Trial locations and contacts

10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Genmab Trial Information contact

+4570202728

clinicaltrials@genmab.com

10 sites in 3 countries

United States5 sites, 5 recruiting

  • West Cancer Center and Research Institute

    Germantown, Tennessee, 38138

    Not yet recruiting

  • START New York Long Island LLC

    Lake Success, New York, 11042

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

    Recruiting

Other trials in United States

Spain4 sites, 4 recruiting

  • Hospital HM Nou Delfos

    Barcelona

    Recruiting

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • START Madrid - Centro Integral Oncologico Clara Campal

    Madrid, 28050

    Recruiting

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223

    Recruiting

Other trials in Spain

Japan1 site, 1 recruiting

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045

    Recruiting

Other trials in Japan

About this study

Official title: First-In-Human, Open-Label, Dose Escalation and Expansion Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of GEN1106 in Participants With Solid Tumors

The purpose of this trial is to learn about the safety and effectiveness of GEN1106 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 tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial.

Read more

For each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 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), open-label, multicenter, dose escalation and expansion trial in participants with urothelial and other cancers who have metastatic disease to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of GEN1106.

Being tested
GEN1106
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEN1106Biological

    Intravenous (IV) infusion.

Study groups in NCT07416123
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalGroups of participants will receive 1 of 4 escalating dose levels of GEN1106.
Receives: Biological: GEN1106
Part 2: Dose RefinementExperimentalGroups of participants will receive up to 3 dose levels of GEN1106 based on the dose escalation data.
Receives: Biological: GEN1106
Part 3: Dose ExpansionExperimentalParticipants will receive up to 2 dose levels of GEN1106 based on the dose escalation / dose refinement data.
Receives: Biological: GEN1106

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)

    Measured: 21 days

  2. Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to approximately 16 months

  3. Part 2 Dose Refinement: Number of Participants with AEs and SAEs

    Measured: Up to approximately 16 months

  4. Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Up to approximately 16 months

Secondary outcomes (12)

  1. Part 1 Dose Escalation and Part 2 Dose Refinement: ORR per RECIST v1.1

    Measured: Up to approximately 16 months

  2. Part 3 Expansion: Number of Participants with AEs and SAEs

    Measured: Up to approximately 16 months

  3. Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Antidrug Antibodies (ADA) to GEN1106

    Measured: Up to approximately 5 months

  4. Part 3 Expansion: Number of Participants with ADA to GEN1106

    Measured: Up to approximately 5 months

  5. Part 1 Dose Escalation and Part 2 Dose Refinement: Plasma Concentrations of GEN1106-related Analytes

    Measured: Up to approximately 5 months

  6. Part 3 Expansion: Plasma Concentrations of GEN1106-related Analytes

    Measured: Up to approximately 5 months

  7. Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR) per RECIST v1.1

    Measured: Up to approximately 16 months

  8. Part 3 Expansion: DCR per RECIST v1.1

    Measured: Up to approximately 16 months

  9. Part 1 Dose Escalation and Part 2 Dose Refinement: Duration of Response (DOR) per RECIST v1.1

    Measured: Up to approximately 16 months

  10. Part 3 Expansion: DOR per RECIST v1.1

    Measured: Up to approximately 16 months

  11. Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR) per RECIST v1.1

    Measured: Up to approximately 16 months

  12. Part 3 Expansion: TTR per RECIST v1.1

    Measured: Up to approximately 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start14 Apr 2026
  3. Primary completion5 Apr 2029 (estimated)
  4. Study completion25 Jun 2029 (estimated)

Resources

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
103 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07416123
Sponsor's protocol ID
GCT1106-01
Other IDs
2025-523760-21-00, jRCT2031260042, 2025
Status last verified
Oct 2026
First submitted
10 Feb 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEN1106 in people with Solid Tumors and Urothelial Carcinoma, run by Genmab at 10 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 5 inclusion and 4 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 10 sites in United States, Spain, Japan. 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 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07416123.

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.

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