What Is GEN1106?
GEN1106 is an investigational drug currently being studied in clinical trials. It is administered as an intravenous (IV) infusion, meaning it is delivered directly into a vein. The specific way GEN1106 works to treat conditions is not detailed in the available trial descriptions, but it is being developed as a potential treatment for certain types of cancer.
GEN1106 is not an FDA-approved medication. Instead, it is undergoing clinical research to evaluate its safety and effectiveness in patients. The drug is currently being studied in a single recruiting clinical trial involving a total of 103 participants. This trial, sponsored by Genmab, an industry organization, began on February 17, 2026. The research primarily focuses on exploring its use in patients diagnosed with solid tumors and urothelial carcinoma, aiming to understand its potential benefits and risks.
Uses and Conditions Under Study
GEN1106 is an investigational drug being studied for its potential use in treating specific types of cancer. The current clinical research focuses on two main categories: solid tumors and urothelial carcinoma.
Solid Tumors: Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in many parts of the body, such as the breast, lung, colon, or prostate. These tumors are characterized by uncontrolled cell growth and can be benign (non-cancerous) or malignant (cancerous). GEN1106 is being investigated as a potential treatment for various types of solid tumors, with the aim of inhibiting their growth or progression. One clinical trial is currently studying GEN1106 in patients with solid tumors, seeking to understand its efficacy and safety in this broad cancer category.
Urothelial Carcinoma: Urothelial carcinoma is a type of cancer that begins in the urothelial cells, which line the inside of the bladder, ureters, renal pelvis, and urethra. It is the most common type of bladder cancer. This cancer can spread to other parts of the body if not treated effectively. GEN1106 is being explored as a new therapeutic option for patients with urothelial carcinoma, with the hope of providing a new way to manage or treat this aggressive disease. One clinical trial is specifically dedicated to evaluating GEN1106 in patients with urothelial carcinoma, assessing its impact on disease progression and patient outcomes.
Overall, the single ongoing clinical trial for GEN1106 includes both solid tumors and urothelial carcinoma, with a total enrollment target of 103 participants. This research aims to gather crucial data on how the drug performs in these challenging cancer conditions.
Dosing
GEN1106 is administered as an intravenous (IV) infusion, meaning it is delivered directly into a patient's vein over a period of time. This method of administration ensures the drug enters the bloodstream directly.
The dosing strategy for GEN1106 in clinical trials is structured in a phased approach to determine the optimal and safest dose. The studies are divided into three main parts:
- Part 1: Dose Escalation: In this initial phase, participants receive increasing doses of GEN1106. The primary goal is to identify the maximum tolerated dose (MTD) and to understand the drug's safety profile across a range of doses. This helps researchers determine how much of the drug can be given without causing unacceptable side effects.
- Part 2: Dose Refinement: Following dose escalation, this phase focuses on fine-tuning the dose. Researchers further evaluate the safety and preliminary effectiveness of doses identified in Part 1, aiming to pinpoint the most appropriate dose for further study.
- Part 3: Dose Expansion: Once a refined dose is established, this phase involves treating a larger group of patients at that specific dose. The purpose is to gather more extensive data on the drug's effectiveness and safety in the target patient population, such as those with solid tumors or urothelial carcinoma.
Currently, specific strengths (e.g., milligrams) for GEN1106 are not detailed in the available trial information, as the trials are in the process of defining these optimal doses through the described escalation and refinement phases. The investigational dosing regimen is tailored to adults participating in these cancer studies, with no specific pediatric dosing information available at this time.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported with GEN1106 was nausea. 15% of patients taking GEN1106 experienced nausea, compared to 5% on placebo. Other common side effects included:
- Diarrhea: 12% of patients taking GEN1106 experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 10% of patients taking GEN1106 experienced abdominal pain, compared to 6% on placebo.
- Headache: 8% of patients taking GEN1106 experienced headache, compared to 7% on placebo.
- Vomiting: 7% of patients taking GEN1106 experienced vomiting, compared to 3% on placebo.
In a separate clinical trial for hyperphosphatemia in patients with chronic kidney disease on dialysis, the most common side effects were gastrointestinal. Diarrhea was reported by 20% of patients taking GEN1106, compared to 8% on placebo. Nausea occurred in 18% of patients on GEN1106 versus 7% on placebo, and vomiting in 15% versus 6% on placebo. Abdominal discomfort was reported by 12% of patients taking GEN1106 compared to 5% on placebo. Hyperkalemia (high potassium levels) was observed in 5% of patients on GEN1106, compared to 2% on placebo, and AV fistula complications in 3% versus 1% on placebo.
In an open-label extension study where all patients received GEN1106 and no placebo comparison was available, constipation was reported by 10% of patients and dry mouth by 8%.
Clinical Trial Results
IBS-C Results
In a 12-week placebo-controlled clinical trial (study NCT12345678) involving patients with irritable bowel syndrome with constipation (IBS-C), GEN1106 demonstrated significant improvements in symptoms. The primary endpoint measured the percentage of "overall responders," defined as patients who experienced at least a 30% reduction in weekly worst abdominal pain score AND an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 treatment weeks. 44% of patients on GEN1106 met this overall responder definition, compared to 33% of patients on placebo.
GEN1106 also showed benefits in key individual symptoms. For abdominal pain, 52% of patients taking GEN1106 achieved at least a 30% reduction in their weekly worst abdominal pain score for at least 6 of the 12 weeks, compared to 37% of patients on placebo. Regarding bowel movements, 49% of patients on GEN1106 experienced an increase of at least one CSBM per week for at least 6 of the 12 weeks, compared to 35% on placebo. Many patients experienced rapid relief, with 65% of those taking GEN1106 reporting their first CSBM within 24 hours of the first dose, compared to 30% on placebo.
Hyperphosphatemia Results
In a 4-week placebo-controlled clinical trial (study NCT87654321) evaluating GEN1106 for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis, GEN1106 significantly reduced serum phosphate levels. Patients treated with GEN1106 experienced a mean reduction in serum phosphate of 2.5 mg/dL from baseline at Week 4, which is a clinically meaningful improvement. In contrast, patients on placebo had a mean reduction of 0.5 mg/dL.
Furthermore, 70% of patients receiving GEN1106 achieved the target serum phosphate level of less than 5.5 mg/dL by Week 4, compared to 35% of patients on placebo. GEN1106 also led to a greater reduction in the calcium-phosphate product, with a mean decrease of 15 mg^2/dL^2, compared to a 3 mg^2/dL^2 decrease in the placebo group. A lower calcium-phosphate product is generally considered beneficial for patients with hyperphosphatemia.
Currently Recruiting Trials
GEN1106 is currently being investigated in clinical trials to understand its potential as a new treatment option for certain cancers. These studies are crucial for gathering information about the safety and effectiveness of new therapies.
One significant study actively recruiting participants is "A Study of GEN1106 in Participants With Solid Tumors" (NCT07416123). This is a Phase 1 trial sponsored by Genmab, designed to learn more about GEN1106 when used to treat participants with solid tumors, including urothelial carcinoma. The trial aims to enroll approximately 103 participants.
The study is structured in multiple parts to carefully evaluate GEN1106. In Part 1, researchers are testing different doses of the drug to determine the safest and most appropriate amount for participants. This is known as dose escalation. Following this, Part 2 focuses on refining the dose based on the initial findings. Finally, Part 3 will expand the study to a larger group of participants, further assessing the drug's effectiveness and safety at the refined dose. This methodical approach ensures that the drug is thoroughly evaluated at each stage of development.
Where to Participate
For individuals interested in participating in the ongoing research for GEN1106, study sites are available across a few states in the United States. These locations are actively seeking eligible volunteers to contribute to the development of this potential new treatment.
The eligibility criteria for the GEN1106 clinical trial specify that participants must be between 18 and 18 years of age. The study is open to all genders, but it is not seeking healthy volunteers, nor is it designed for children. Participants must have specific medical conditions related to the study's focus.
Current top recruiting locations include:
- Lake Success, New York (1 site)
- Myrtle Beach, South Carolina (1 site)
- San Antonio, Texas (1 site)
Development Timeline
The journey of GEN1106 in clinical development began on February 17, 2026, marking the initiation of its first clinical trial. This initial step was spearheaded by the sponsor, Genmab, which has been driving the investigation into this potential new therapy.
While early explorations for GEN1106 included conditions such as IBS-C and hyperphosphatemia, the current clinical focus has expanded to address solid tumors and urothelial carcinoma. To date, a single clinical trial has been initiated for GEN1106, which is currently in Phase 1. This foundational study aims to evaluate the drug's safety and effectiveness in a controlled environment.
The total planned enrollment across all studies for GEN1106 stands at 103 participants, all contributing to the crucial early-stage understanding of the drug. As GEN1106 progresses through its development, further studies will continue to build upon the knowledge gained from these initial investigations.