A Study of GEN1106 in Participants With Solid Tumors

NCT07416123 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: GCT1106-012025-523760-21-00
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (4)

• Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)

  21 days

• Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to approximately 16 months

• Part 2 Dose Refinement: Number of Participants with AEs and SAEs

  Up to approximately 16 months

• Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to approximately 16 months

Secondary Outcomes (12)

• Part 1 Dose Escalation and Part 2 Dose Refinement: ORR per RECIST v1.1

  Up to approximately 16 months

• Part 3 Expansion: Number of Participants with AEs and SAEs

  Up to approximately 16 months

• Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Antidrug Antibodies (ADA) to GEN1106

  Up to approximately 5 months

• Part 3 Expansion: Number of Participants with ADA to GEN1106

  Up to approximately 5 months

• Part 1 Dose Escalation and Part 2 Dose Refinement: Plasma Concentrations of GEN1106-related Analytes

  Up to approximately 5 months

Study Arms (3)

Part 1: Dose Escalation

EXPERIMENTAL

Groups of participants will receive 1 of 4 escalating dose levels of GEN1106.

Biological: GEN1106

Part 2: Dose Refinement

EXPERIMENTAL

Groups of participants will receive up to 3 dose levels of GEN1106 based on the dose escalation data.

Biological: GEN1106

Part 3: Dose Expansion

EXPERIMENTAL

Participants will receive up to 2 dose levels of GEN1106 based on the dose escalation / dose refinement data.

Biological: GEN1106

Interventions

GEN1106 BIOLOGICAL

Intravenous (IV) infusion.

Part 1: Dose Escalation; Part 2: Dose Refinement; Part 3: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have progressed on or after standard of care (SoC) therapy, which should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, and enfortumab vedotin (EV), if applicable for the tumor type, or for whom there is no available standard therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1106 may be beneficial, in the opinion of the investigator.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (3)

START New York Long Island LLC

Lake Success, New York, 11042, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Central Study Contacts

Genmab Trial Information

CONTACT

+4570202728; clinicaltrials@genmab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization will not be used for the Dose Escalation part. In the Dose Refinement and Expansion parts, randomization may be used.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): April 5, 2029
• Study Completion (Estimated): June 25, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)