A Phase 1 interventional study of GEN1106 in Solid Tumors and Urothelial Carcinoma, sponsored by Genmab. Recruiting at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Genmab · Phase 1, Interventional, and Treatment
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.
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.
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 181 are open to participants now.
This study's planned enrollment of 103 is above the median of 50 across 500 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Genmab is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 13 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Groups of participants will receive 1 of 4 escalating dose levels of GEN1106.
Biological: GEN1106
Groups of participants will receive up to 3 dose levels of GEN1106 based on the dose escalation data.
Biological: GEN1106
Participants will receive up to 2 dose levels of GEN1106 based on the dose escalation / dose refinement data.
Biological: GEN1106
Intravenous (IV) infusion.
Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 21 days
Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to approximately 16 months
Part 2 Dose Refinement: Number of Participants with AEs and SAEs
Time frame: Up to approximately 16 months
Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 16 months
Part 1 Dose Escalation and Part 2 Dose Refinement: ORR per RECIST v1.1
Time frame: Up to approximately 16 months
Part 3 Expansion: Number of Participants with AEs and SAEs
Time frame: Up to approximately 16 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Antidrug Antibodies (ADA) to GEN1106
Time frame: Up to approximately 5 months
Part 3 Expansion: Number of Participants with ADA to GEN1106
Time frame: Up to approximately 5 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Plasma Concentrations of GEN1106-related Analytes
Time frame: Up to approximately 5 months
Part 3 Expansion: Plasma Concentrations of GEN1106-related Analytes
Time frame: Up to approximately 5 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to approximately 16 months
Part 3 Expansion: DCR per RECIST v1.1
Time frame: Up to approximately 16 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Duration of Response (DOR) per RECIST v1.1
Time frame: Up to approximately 16 months
Part 3 Expansion: DOR per RECIST v1.1
Time frame: Up to approximately 16 months
Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR) per RECIST v1.1
Time frame: Up to approximately 16 months
Part 3 Expansion: TTR per RECIST v1.1
Time frame: Up to approximately 16 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2029, 35 months after the start.
Of 62 industry-sponsored phase 1 interventional studies under Carcinoma, Transitional Cell, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 57. This study's planned 35 months is below that.
Counting every sponsor, half of 99 studies reached it within 44 months; a quarter within 31 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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