A Study of GEN1106 in Participants With Solid Tumors

Part of paid clinical trials in Lake Success, New York.

Sponsor
Genmab
Study ID
NCT07416123
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GEN1106 — BIOLOGICAL
    Intravenous (IV) infusion.

Study Details

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.

Key Dates

Start date
Apr 14, 2026
Status verified
Jun 2026
Primary completion
Apr 5, 2029
Completion
Jun 25, 2029

Study Design

Enrollment
103 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    Groups of participants will receive 1 of 4 escalating dose levels of GEN1106.
  • Experimental: Part 2: Dose Refinement
    Groups of participants will receive up to 3 dose levels of GEN1106 based on the dose escalation data.
  • Experimental: Part 3: Dose Expansion
    Participants will receive up to 2 dose levels of GEN1106 based on the dose escalation / dose refinement data.

Primary Outcome Measure

Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
START New York Long Island LLCLake SuccessNew York11042-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-

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