Recruiting
Phase 1

GEN1106

Sponsor:

Genmab

Code:

NCT07416123

Conditions

Solid Tumors

Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GEN1106

Study Details

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.

Conditions

Solid Tumors

Urothelial Carcinoma

Study ID

NCT07416123

Start date

Apr 14, 2026

Status verified date

Aug, 2026

Completion date

Jun 25, 2029

Anticipated

Primary completion date

Apr 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

103 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

GEN1106

Intravenous (IV) infusion.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Genmab Trial Information

+4570202728clinicaltrials@genmab.com

Locations

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

START New York Long Island LLC

Recruiting

Lake Success, New York, United States, 11042

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

South Texas Accelerated Research Therapeutics

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Genmab

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genmab on 2026-08-12.