A Study of GEN1106 in Participants With Solid Tumors

NCT07416123 · tracked via the Priya Life Science Spain tracker

Sponsor

Genmab

Phase

Phase 1

Started

2026-04-14

Last updated

2026-09-10

Condition(s) studied

Solid TumorsUrothelial Carcinoma

Investigational drug(s) / intervention(s)

GEN1106

GEN1106: Intravenous (IV) infusion.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (10)

Facility	City	Region	Status
Yale Cancer Center	New Haven	Connecticut	Recruiting
START New York Long Island LLC	Lake Success	New York	Recruiting
Carolina Urologic Research Center	Myrtle Beach	South Carolina	Recruiting
West Cancer Center and Research Institute	Germantown	Tennessee	Not Yet Recruiting
South Texas Accelerated Research Therapeutics	San Antonio	Texas	Recruiting
National Cancer Center Hospital	Chuo Ku	Tokyo	Recruiting
Hospital HM Nou Delfos	Barcelona	Spain	Recruiting
START Madrid - Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain	Recruiting
START Madrid - Centro Integral Oncologico Clara Campal	Madrid	Spain	Recruiting
Hospital Universitario Quironsalud Madrid	Madrid	Spain	Recruiting

More Genmab trials in Spain

GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors Active, not recruiting

Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome Active, not recruiting

Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer Recruiting

A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) Active, not recruiting

Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) Active, not recruiting

Other trials for the same condition

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) Active, not recruiting

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options Active, not recruiting

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours) Recruiting

BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors Active, not recruiting

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07416123 on ClinicalTrials.gov ↗ ← All trials in Spain