In short
Denikitug (also known as GS-1811) is an investigational protein-based substance being studied in advanced gastrointestinal cancers. It has no marketing authorisation and is given by intravenous infusion. Two Phase 2 trials have tested denikitug alone or with other cancer medicines in adults with advanced colorectal cancer (170 participants) and metastatic gastric or esophageal cancers (120 participants).
Key points
- Denikitug is an investigational antibody-like protein with no marketing authorisation.
- It is being studied in Phase 2 trials for advanced colorectal and gastric/esophageal cancers.
- One completed trial enrolled 170 participants with advanced microsatellite stable colorectal cancer.
- A second authorised trial enrolled 120 participants with HER2-negative gastric, GEJ, or esophageal adenocarcinomas.
- Both trials measure objective response rate (ORR) according to RECIST Version 1.1.
- Denikitug is given as a solution for intravenous infusion.
What is denikitug?
Denikitug (also known as GS-1811) is an investigational protein-based substance developed by Gilead Sciences Inc. It is a protein of the type classified as \"Protein - Other\" in the EU Clinical Trials Information System, meaning it is a biological medicine rather than a chemically synthesised small molecule. Denikitug has no marketing authorisation in the product records of the trials listed here, so it is still an investigational substance. The therapeutic area for denikitug is neoplasms (cancers).
How does denikitug work?
The registry records do not describe the molecular target or mechanism of action of denikitug. As a protein-based substance given by infusion, it belongs to the class of biological medicines, but the specific way it acts on cancer cells is not stated in the available data.
Which conditions is denikitug studied for?
- Advanced microsatellite stable (MSS) colorectal cancer (CRC) — a type of bowel cancer in which the tumour cells do not show the DNA repair defect called microsatellite instability. This trial is completed.
- HER2-negative, unresectable, recurrent, and/or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinomas — cancers of the stomach, the junction between stomach and food pipe, and the food pipe itself that cannot be removed by surgery, have come back, or have spread, and do not overexpress the HER2 protein. This trial is authorised.
How is denikitug given?
Denikitug is formulated as a solution for infusion and is given by intravenous use. In the trials, denikitug is provided as GS-1811 150 mg/vial concentrate for solution for infusion.
What do the clinical trials show?
Two Phase 2 trials of denikitug are listed in the EU Clinical Trials Information System. Both are interventional studies that measure objective response rate (ORR), which is the percentage of participants who achieve a complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.
Which conditions are studied in the trials?
The first trial studied denikitug alone or with nivolumab or with trifluridine-tipiracil and bevacizumab in adults with advanced microsatellite stable colorectal cancer. The second trial studied denikitug alone or with nivolumab or with ramucirumab and paclitaxel in adults with HER2-negative, unresectable, recurrent, and/or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinomas.
What phases and status do the trials have?
Both trials are Phase 2 studies. The colorectal cancer trial is completed, while the gastric and esophageal cancer trial is authorised.
Who can take part in these trials?
The colorectal cancer trial enrolled 170 adults with advanced microsatellite stable colorectal cancer. The gastric and esophageal cancer trial enrolled 120 adults with HER2-negative, unresectable, recurrent, and/or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinomas.
What are the trials measuring?
Both trials use objective response rate (ORR) as the primary outcome. ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.
What side effects are known?
No side effect information is provided in the registry records or supplementary sources for denikitug.