In short
CR-001 is an investigational drug being studied in a Phase 1/2 clinical trial for adults with locally advanced or metastatic solid tumours. The trial, registered as NCT07335497, is currently authorised and plans to enrol 490 participants. It is given by intravenous (IV) infusion, and the study is designed to assess safety, how the body processes the drug, and early signs of antitumour activity.
Key points
- CR-001 is an investigational drug given by intravenous infusion.
- The registered trial is a Phase 1/2 study in adults with locally advanced or metastatic solid tumours.
- The trial is currently authorised and plans to enrol 490 participants.
- The study is open-label, meaning both participants and researchers know which treatment is given.
- The main goals are to assess safety, tolerability, and antitumour activity.
- The trial uses a dose escalation design followed by dose expansion.
What is CR-001?
CR-001 is an investigational drug. In the source data, its full name is given only as CR-001, with no other names, development codes, or trade names listed. There is no marketing authorisation recorded for this substance in the provided registry information, which means it is still being studied in clinical research rather than being available as an approved medicine. The trial record describes CR-001 as a drug given by intravenous infusion, but does not state its chemical class or whether it is a small molecule or a protein-based substance.
How does CR-001 work?
The registry record for CR-001 does not describe a mechanism of action, a molecular target, or the biological pathway that the drug is intended to affect. The study objectives focus on characterising safety, tolerability, pharmacokinetics (how the body absorbs, distributes, metabolises, and eliminates the drug), pharmacodynamics (the effects the drug has on the body), and antitumour activity. Because the mechanism is not stated in the available data, this section cannot describe how CR-001 is thought to work at a molecular level.
Which conditions is CR-001 studied for?
- Locally advanced or metastatic solid tumours — cancers that have grown into nearby tissues or spread to other parts of the body. The trial includes adult participants with this broad category of disease, without specifying a single tumour type.
How is CR-001 given?
CR-001 is given as an intravenous (IV) infusion, meaning it is delivered directly into a vein. The registry record does not provide the dose, the frequency of administration, the duration of each infusion, or the number of treatment cycles planned. The dose escalation design suggests that different participant groups will receive increasing dose levels during the study.
What do the clinical trials show?
One registered trial is available for CR-001: a Phase 1/2, multicentre, open-label study in adults with locally advanced or metastatic solid tumours. The study is currently authorised and plans to enrol 490 participants. It uses a dose escalation and dose expansion design: in the dose escalation part, successive groups of participants receive increasing dose levels of CR-001 to characterise safety and tolerability; in the dose expansion part, selected doses are studied further. The study is open-label, meaning both participants and researchers know which treatment is being given.
The primary outcomes measured in this trial are: the incidence and nature of dose-limiting toxicities (DLTs) during Cycle 1, which is 28 days of CR-001 administration; the maximum tolerated dose (MTD), if applicable; the incidence, nature, and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE); and the severity and nature of TEAEs leading to dose modifications and treatment discontinuation. The trial also aims to evaluate pharmacokinetics, pharmacodynamics, and antitumour activity.
The trial is multicentre, meaning it takes place at more than one hospital or research site. The registry record does not state which countries or sites are involved, the planned start date, or the expected completion date. It also does not describe specific eligibility criteria beyond adult participants with locally advanced or metastatic solid tumours.
What side effects are known?
No side effects of CR-001 are reported in the provided data. The trial is designed to collect information on treatment-emergent adverse events and serious adverse events, but no results from this study are available yet.