In short
NMS-01940153E is an investigational cancer medicine with no marketing authorisation, studied in a completed Phase 2 trial for unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The trial enrolled 90 patients and tested NMS-01940153E in combination with atezolizumab, with or without decitabine priming. Its main goal was to measure the objective response rate (ORR), the proportion of patients whose tumours shrink or disappear.
NMS-01940153E is the short name for N-(2,6-DIETHYLPHENYL)-8-({4-[4-(DIMETHYLAMINO)PIPERIDIN-1-YL]-2-METHOXYPHENYL}AMINO)-1-METHYL-4,5-DIHYDRO-1H-PYRAZOLO[4,3-H]QUINAZOLINE-3-CARBOXAMIDE PHOSPHATE, an investigational cancer medicine developed by Nerviano Medical Sciences.
Key points
- NMS-01940153E is an investigational substance with no marketing authorisation.
- It was studied in unresectable hepatocellular carcinoma, a liver cancer that cannot be removed by surgery.
- The trial was a Phase 2 study that enrolled 90 patients.
- Patients had received prior treatment with immune checkpoint inhibitors.
- The main measure was objective response rate (ORR), assessed with RECIST 1.1.
- The trial is completed.
What is NMS-01940153E?
NMS-01940153E is a chemically synthesised substance classified in the therapeutic area of neoplasms, meaning it is studied in cancer. It has no marketing authorisation in the product records, so it remains an investigational medicine. The substance is supplied by Nerviano Medical Sciences.
How does NMS-01940153E work?
The registry records do not describe the molecular target or mechanism of action of NMS-01940153E. The trial studied it together with atezolizumab, an immune checkpoint inhibitor, and with or without low-dose decitabine priming, but the exact way NMS-01940153E acts on cancer cells is not stated in the available data.
Which conditions is NMS-01940153E used or studied for?
- Unresectable hepatocellular carcinoma (HCC) — a primary liver cancer that cannot be removed by surgery, in patients who had already received immune checkpoint inhibitors.
How is NMS-01940153E given?
NMS-01940153E is prepared as a powder for solution for infusion and given by intravenous infusion. In the trial, the dose was 100 mg per square metre of body surface area.
What do the clinical trials show?
One completed Phase 2 trial investigated NMS-01940153E in 90 adults with unresectable hepatocellular carcinoma who had previously been treated with immune checkpoint inhibitors. The study tested NMS-01940153E in combination with atezolizumab, with or without low-dose decitabine priming.
What is the trial measuring?
The primary outcome was the objective response rate (ORR), calculated as the proportion of evaluable patients who achieved a confirmed complete response or partial response, assessed by the investigator using RECIST 1.1 criteria. RECIST 1.1 is a standard way of measuring tumour shrinkage in imaging scans.
Who can take part in this trial?
The trial enrolled adult patients with unresectable hepatocellular carcinoma who had received prior treatment with anti-cancer medicines, specifically immune checkpoint inhibitors.
The study is completed, so it is no longer recruiting participants.
What side effects are known?
The available registry records do not list side effects for NMS-01940153E.