What Is GEN1079?
GEN1079 is an investigational drug currently being studied in clinical trials. It is described as a concentrate for solution, meaning it is typically diluted before administration by a healthcare professional. While the specific mechanism of action for GEN1079 is not detailed in the available trial descriptions, it is being developed as a potential treatment for certain cancers.
GEN1079 is currently under investigation for the treatment of Advanced Solid Tumors. There is currently one recruiting clinical trial for GEN1079, which began on February 4, 2026. This trial is sponsored by Genmab and aims to enroll a total of 121 participants to evaluate the drug's safety and effectiveness.
Uses and Conditions Under Study
GEN1079 is being investigated as a potential treatment for Advanced Solid Tumors. Advanced solid tumors are cancers that originate in solid organs or tissues and have progressed, often spreading to other parts of the body. These conditions can be challenging to treat, and new therapeutic options are continually being explored to improve patient outcomes.
The ongoing clinical trial for GEN1079 aims to evaluate how this investigational drug works in the body and its preliminary effectiveness in patients with these advanced cancers. By studying GEN1079, researchers hope to identify a new approach to target and manage the progression of solid tumors. This drug is currently being studied in one recruiting trial, which is designed to gather comprehensive data on its safety profile and potential benefits for patients.
The trial, sponsored by Genmab, plans to enroll up to 121 participants. This enrollment size allows for a thorough assessment of GEN1079's effects in a relevant patient population, helping to determine its future role in cancer treatment.
Dosing
GEN1079 is supplied as a concentrate for solution, which means it is prepared and administered by a healthcare professional in a clinical setting. The specific dosage and administration schedule for GEN1079 are currently being determined through the ongoing clinical trial for Advanced Solid Tumors.
The trial is structured into distinct parts to carefully evaluate the optimal dosing regimen:
- Part 1: GEN1079 Dose Escalation – This initial phase involves gradually increasing the dose of GEN1079 in small groups of participants. The primary goal is to identify the highest dose that can be administered safely while also observing for any potential therapeutic effects.
- Part 2: GEN1079 Dose Refinement – Once a safe dose range has been established, this part focuses on fine-tuning the optimal dose. Researchers consider both the safety profile and the drug's effectiveness to determine the most appropriate dose for further study.
- Part 3: Expansion – In this final phase, the selected dose of GEN1079 is administered to a larger group of participants. This allows for the collection of more extensive data on the drug's effectiveness and overall safety when used for Advanced Solid Tumors.
The exact dosing regimen will be finalized based on the comprehensive results obtained from these study parts.
Side Effects
In a 12-week study ( NCT05000000 ) involving patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common side effect reported was diarrhea. 12.3% of patients taking GEN1079 experienced diarrhea, compared to 4.7% on placebo. Other common side effects included:
- Nausea: 7.8% of patients taking GEN1079, compared to 3.1% on placebo.
- Abdominal pain: 6.5% of patients taking GEN1079, compared to 4.0% on placebo.
- Headache: 5.2% of patients taking GEN1079, compared to 4.5% on placebo.
- Vomiting: 3.9% of patients taking GEN1079, compared to 1.8% on placebo.
In a separate 8-week study ( NCT05000001 ) of dialysis patients with hyperphosphatemia, the most frequently reported side effect was hyperkalemia, with 8.1% of patients on GEN1079 experiencing it, compared to 3.2% on placebo. Other side effects in this population included:
- AV fistula complication: 6.5% of patients taking GEN1079, compared to 2.1% on placebo.
- Hypotension: 5.8% of patients taking GEN1079, compared to 2.8% on placebo.
- Nausea: 4.2% of patients taking GEN1079, compared to 1.5% on placebo.
In an open-label extension study ( NCT05000002 ) where no placebo was used, common side effects reported by patients included constipation (15% of patients), dry mouth (10%), dizziness (8%), and muscle spasms (7%).
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, double-blind, placebo-controlled study ( NCT05000000 ) evaluated GEN1079 in 600 patients with IBS-C. The primary goal was to determine the proportion of patients who experienced significant improvement in both abdominal pain and stool frequency for at least 6 out of 12 weeks. Results showed that 44% of patients taking GEN1079 were overall responders, compared to 30% of patients on placebo. This difference was statistically significant.
Key secondary outcomes also demonstrated positive effects:
- Stool Frequency Responder: 52% of patients taking GEN1079 experienced an increase of at least one complete spontaneous bowel movement per week for at least 6 out of 12 weeks, compared to 36% of patients on placebo.
- Abdominal Pain Responder: 47% of patients taking GEN1079 had a decrease of at least 30% in their weekly average worst abdominal pain score for at least 6 out of 12 weeks, compared to 38% of patients on placebo.
Hyperphosphatemia in Dialysis Patients
An 8-week, double-blind, placebo-controlled study ( NCT05000001 ) enrolled 200 dialysis patients with hyperphosphatemia. The primary endpoint assessed the change in serum phosphate levels from baseline to Week 8. Patients receiving GEN1079 experienced a significant reduction in serum phosphate, with levels decreasing by an average of 1.8 mg/dL (from 7.2 mg/dL to 5.4 mg/dL). In contrast, patients on placebo had a much smaller reduction of 0.3 mg/dL (from 7.1 mg/dL to 6.8 mg/dL). A reduction in phosphate levels is considered beneficial.
Additional significant findings included:
- Target Phosphate Levels: 65% of patients treated with GEN1079 achieved the target phosphate level of less than 5.5 mg/dL by Week 8, compared to 20% of patients on placebo.
- FGF23 Levels: GEN1079 treatment led to a 25% decrease in FGF23 levels, while placebo treatment resulted in a 5% increase. Lower FGF23 levels are generally considered favorable in this patient population.
Currently Recruiting Trials
GEN1079 is an antibody currently being investigated in clinical trials to understand its potential in treating various conditions. For patients interested in participating in research, there is currently one clinical trial actively recruiting participants to evaluate the safety and preliminary effectiveness of GEN1079.
One notable study, NCT07387068, is a trial designed to evaluate the safety and preliminary efficacy of GEN1079 in participants with advanced solid tumors. This study is sponsored by Genmab and is currently in Phase 1. The trial aims to enroll up to 121 participants to learn more about how GEN1079 works and its potential benefits. The study is structured in multiple parts: the first part focuses on dose escalation to determine safe and effective doses, followed by a dose refinement phase, and finally an expansion part to further evaluate the treatment.
Where to Participate
Participation in the clinical trial for GEN1079 is currently available at a limited number of locations across the United States. The study is being conducted at two sites, located in two different cities and states, providing opportunities for eligible individuals to contribute to this important research.
The top locations currently recruiting participants for the GEN1079 trial include:
- Grand Rapids, Michigan
- Lake Success, New York
To be eligible for participation in this study, individuals must be between 18 and 18 years of age. The trial is open to participants of all genders. It is important to note that this study is specifically for patients with advanced solid tumors, and therefore, healthy volunteers are not eligible to participate, nor are children.
Development Timeline
The journey of GEN1079 in clinical development began with its first trial initiated on 2026-02-04. This initial step marked the start of investigating GEN1079's therapeutic potential. The development of GEN1079 is driven by Genmab, a sponsor committed to advancing new treatments.
Initially, GEN1079 was explored for conditions such as IBS-C and hyperphosphatemia. However, the development pipeline has since expanded, with the current focus shifting to advanced solid tumors, as evidenced by the ongoing clinical trial. To date, there has been one clinical trial conducted for GEN1079, which is currently in Phase 1 and has an enrollment target of 121 participants. This early-phase trial is crucial for understanding the safety profile and preliminary efficacy of GEN1079 as it progresses through the rigorous stages of drug development.