GEN1106 for People With Solid Tumors, Including Urothelial Carcinoma
Tests the safety of GEN1106 in adults with solid tumors.
Plain-language title generated from the registry record
Registry title: A Study of GEN1106 in Participants With Solid Tumors
Key facts
- Where
- Barcelona and Madrid, SpainSee the 4 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with solid tumors that have not responded to, or cannot be treated with, standard therapies. Parts 2 and 3 are for people with metastatic urothelial carcinoma.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Cancer with measurable disease (RECIST v1.1). Part 1: cancer types set by the protocol. Parts 2 and 3: metastatic urothelial carcinoma, confirmed by tissue or cell tests.
- Earlier treatment
- Must have had all standard therapies known to help survival or quality of life for their tumor type, or have progressed on, not tolerated, or been unable to receive them. These include chemotherapy, anti-PD-1/PD-L1 therapy and enfortumab vedotin, where applicable.
Main reasons for not taking part
- Earlier treatment with a topoisomerase 1 inhibitor-based antibody-drug conjugate
- An anticancer drug within 4 weeks, or within 5 half-lives of the drug if that is shorter, before trial treatment
- Serious side effects from earlier cancer treatment that have not eased to grade 1 or lower, with some listed exceptions
Read by machine on 12 November 2026.
Where in Spain
- Hospital HM Nou DelfosBarcelona, SpainTaking people
- Hospital Universitario Quirónsalud MadridMadrid, SpainTaking people
- START Madrid / Centro Integral Oncologico Clara CampalMadrid, SpainTaking people
- START Madrid / Hospital Universitario Fundacion Jimenez DiazMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Genmab
- Trial code
- NCT07416123EU 2025-523760-21-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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).
Exclusion: 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.