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.
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
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.
10 sites in 3 countries
United States5 sites, 5 recruiting
- Not yet recruiting
West Cancer Center and Research Institute
Germantown, Tennessee, 38138
- 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
Spain4 sites, 4 recruiting
- 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
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
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.
- Conditions
- Solid Tumors, Urothelial Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Groups of participants will receive 1 of 4 escalating dose levels of GEN1106. Receives: Biological: GEN1106 |
| Part 2: Dose Refinement | Experimental | Groups of participants will receive up to 3 dose levels of GEN1106 based on the dose escalation data. Receives: Biological: GEN1106 |
| Part 3: Dose Expansion | Experimental | Participants 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.
Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: 21 days
Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to approximately 16 months
Part 2 Dose Refinement: Number of Participants with AEs and SAEs
Measured: Up to approximately 16 months
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)
Part 1 Dose Escalation and Part 2 Dose Refinement: ORR per RECIST v1.1
Measured: Up to approximately 16 months
Part 3 Expansion: Number of Participants with AEs and SAEs
Measured: Up to approximately 16 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Antidrug Antibodies (ADA) to GEN1106
Measured: Up to approximately 5 months
Part 3 Expansion: Number of Participants with ADA to GEN1106
Measured: Up to approximately 5 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Plasma Concentrations of GEN1106-related Analytes
Measured: Up to approximately 5 months
Part 3 Expansion: Plasma Concentrations of GEN1106-related Analytes
Measured: Up to approximately 5 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR) per RECIST v1.1
Measured: Up to approximately 16 months
Part 3 Expansion: DCR per RECIST v1.1
Measured: Up to approximately 16 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Duration of Response (DOR) per RECIST v1.1
Measured: Up to approximately 16 months
Part 3 Expansion: DOR per RECIST v1.1
Measured: Up to approximately 16 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR) per RECIST v1.1
Measured: Up to approximately 16 months
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.
- First posted17 Feb 2026
- Study start14 Apr 2026
- Primary completion5 Apr 2029 (estimated)
- Study completion25 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 103 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
- 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