Actively Recruiting
A Study of GEN1106 in Participants With Solid Tumors
Led by Genmab · Updated on 2026-05-05
103
Participants Needed
4
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of GEN1106 in Participants With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have progressed on or after standard of care therapy, including chemotherapy, anti-PD-1/PD-L1 therapies, and enfortumab vedotin if applicable, or have no available standard therapy likely to benefit, as judged by the investigator.
- Have measurable disease according to RECIST v1.1.
- Have an Eastern Cooperative Oncology Group performance status score of 0 to 1 at screening.
- Part 1: Have a confirmed diagnosis of cancer as specified in the protocol.
- Parts 2 and 3: Have a confirmed diagnosis of metastatic urothelial carcinoma.
You will not qualify if you...
- Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate therapy.
- Treatment with an anticancer agent within 4 weeks or within 5 half-lives of the drug, whichever is shorter, before trial treatment.
- Have clinically significant toxicities from previous anticancer therapies that have not resolved to baseline 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.
- Other protocol-defined inclusion and exclusion criteria may apply.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
START New York Long Island LLC
Lake Success, New York, United States, 11042
Actively Recruiting
2
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
3
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Actively Recruiting
4
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan, 104-0045
Actively Recruiting
Research Team
G
Genmab Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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