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Sponsor: Genmab
Conditions: Solid Tumors, Urothelial Carcinoma
Interventions: GEN1106
Countries: United States, Japan, Spain
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- New Haven, Connecticut, United States
- Lake Success, New York, United States
- Myrtle Beach, South Carolina, United States
- Germantown, Tennessee, United States
- San Antonio, Texas, United States
- Chuo Ku, Tokyo, Japan
- Barcelona, Spain
- Madrid, Spain
- Madrid, Spain
- Madrid, Spain