NCT07416123 A Study of GEN1106 in Participants With Solid Tumors
| NCT ID | NCT07416123 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Genmab |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 103 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2029-04-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 103 participants in total. It began in 2026-04-14 with a primary completion date of 2029-04-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Key Inclusion Criteria: * 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). Key Exclusion Criteria: * 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.
Contact & Investigator
Study Official
STUDY DIRECTOR
Genmab
Frequently Asked Questions
Who can join the NCT07416123 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07416123 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07416123 currently recruiting?
Yes, NCT07416123 is actively recruiting participants. Contact the research team at clinicaltrials@genmab.com for enrollment information.
Where is the NCT07416123 trial being conducted?
This trial is being conducted at New Haven, United States, Lake Success, United States, Myrtle Beach, United States, Germantown, United States and 6 additional locations.
Who is sponsoring the NCT07416123 clinical trial?
NCT07416123 is sponsored by Genmab. The principal investigator is Study Official at Genmab. The trial plans to enroll 103 participants.