In short
LP-184 is an investigational cancer medicine being studied in urothelial carcinoma, a type of bladder cancer. It belongs to a class of drugs called acylfulvenes. One registered clinical trial is currently authorised, with a planned enrollment of 39 participants, testing the drug in a Phase 1 setting for tumours that are positive for the PTGR1 protein and have DNA repair deficiencies.
Key points
- LP-184 is an acylfulvene, a type of investigational cancer drug.
- The registered trial is in Phase 1 and is currently authorised.
- It is being studied for PTGR1-positive, DNA repair deficient urothelial carcinoma.
- The planned enrollment is 39 participants.
- The trial measures dose-limiting toxicity, recommended Phase 2 dose, and objective response rate.
- LP-184 is given as an intravenous infusion.
What is LP-184?
LP-184 is an investigational substance, meaning it is not yet approved as a medicine. It is a chemically synthesised compound belonging to the acylfulvene class, a group of drugs being developed to target certain cancers. The full chemical name of LP-184 is N-hydroxy-N-{[(6'R)-6'-hydroxy-2',4',6'-trimethyl-7'-oxo-6',7'-dihydrospiro[cyclopropane-1,5'-inden]-3'-yl]methyl}urea. LP-184 is the short label for this substance.
In the EU Clinical Trials Information System (CTIS), LP-184 is listed as an investigational medicinal product. It is being studied in the field of oncology, specifically for urothelial carcinoma, a cancer that starts in the cells lining the bladder and other parts of the urinary tract. The trial record describes it as intended for tumours that are PTGR1-positive and have deficiencies in DNA repair.
How does LP-184 work?
Acylfulvenes like LP-184 are designed to damage the DNA of cancer cells. The trial record focuses on tumours that are PTGR1-positive and have DNA repair deficiencies. PTGR1 is an enzyme; when a tumour is PTGR1-positive, it produces this enzyme, which may make it more sensitive to drugs like LP-184. Cancer cells with defective DNA repair mechanisms are less able to fix damage caused by such drugs, which may lead to cell death. The exact molecular interaction of LP-184 is not described in detail in the registry data.
Which conditions is it studied for?
- Urothelial carcinoma – a cancer of the urothelium, the tissue lining the bladder, renal pelvis, ureters, and urethra. The trial specifically targets tumours that are PTGR1-positive and have DNA repair deficiencies.
How is LP-184 given?
LP-184 is given as an intravenous infusion, meaning it is administered directly into a vein over a period of time. The registry record lists this as the only route of administration for the current trial.
What do the clinical trials show?
There is one registered clinical trial for LP-184 in the provided data. It is currently in the status Authorised, which means it has received approval to proceed but may not yet have started recruiting participants. The trial is a combined Phase 1b/Phase 2 interventional study with a planned enrollment of 39 participants.
The trial is designed in two parts. The Phase 1b part aims to characterise the safety and tolerability of LP-184, measuring dose-limiting toxicity (DLT) according to CTCAE version 5.0 and establishing the recommended Phase 2 dose (RP2D). The Phase 2 part will evaluate antitumor activity by measuring the objective response rate (ORR) according to RECIST criteria version 1.1.
Who can take part in this trial? The registry data does not provide detailed inclusion or exclusion criteria. The trial is aimed at patients with PTGR1-positive, DNA repair deficient urothelial carcinoma, as stated in the trial title.
What side effects are known?
The registry data does not include a list of side effects for LP-184. Since the trial is in Phase 1, one of its main goals is to determine the safety profile and identify dose-limiting toxicities, which are side effects severe enough to prevent increasing the dose.