NCT07416123RecruitingPhase 1
A Study of GEN1106 in Participants With Solid Tumors
First-In-Human, Open-Label, Dose Escalation and Expansion Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of GEN1106 in Participants With Solid Tumors
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 103 (estimated)
- First submitted
- 10 Feb 2026
- Start date
- 14 Apr 2026
- Primary completion date
- 5 Apr 2029
- Lead sponsor
- Genmab
- Diseases
- Bladder cancer
- NCT number
- NCT07416123
- EU CT number
- 2025-523760-21-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 103
- From 14 Apr 2026 to the primary completion date, 5 Apr 2029
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital HM Nou Delfos Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Quirónsalud Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| START Madrid / Centro Integral Oncologico Clara Campal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| START Madrid / Hospital Universitario Fundacion Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| West Cancer Center and Research Institute Coordinator of this site? Confirm its status | Germantown | United States | Not yet recruiting |
| START New York Long Island, LLC Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| South Texas Accelerated Research Therapeutics Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.