In short
INCA33890 is an investigational antibody currently being studied in a Phase 3 clinical trial for the first-line treatment of metastatic microsatellite stable colorectal cancer (MSS CRC). The trial, which is authorised but not yet recruiting, plans to enrol 700 participants and will compare standard-of-care chemotherapy plus bevacizumab with or without INCA33890. The main measure is progression-free survival, meaning the time patients live without their cancer getting worse.
INCA33890 is an investigational antibody being developed for the treatment of metastatic microsatellite stable colorectal cancer (MSS CRC). The substance is currently being evaluated in a Phase 3 clinical trial that compares standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of this condition.
Key points
- Phase 3 trial in metastatic microsatellite stable colorectal cancer
- Planned enrolment of 700 participants
- Status: Authorised, not yet recruiting
- Compares standard chemotherapy plus bevacizumab with or without INCA33890
- Main measure: progression-free survival assessed by independent central review
- INCA33890 is given by intravenous infusion at a dose of 900 mg
What is INCA33890?
INCA33890 is an investigational antibody. The name INCA33890 is a development code; no trade name has been assigned. The substance is not yet authorised as a medicine in any country. It is being studied in oncology, specifically in colorectal cancer that has spread to other parts of the body (metastatic) and is microsatellite stable, meaning the cancer cells do not have a particular type of genetic instability called microsatellite instability.
How does INCA33890 work?
The registry record for the Phase 3 trial does not describe the mechanism of action of INCA33890 in detail. The trial is designed to evaluate whether adding INCA33890 to standard-of-care chemotherapy and bevacizumab improves outcomes compared with placebo. The specific molecular target of INCA33890 is not stated in the available trial data.
Which conditions is it studied for?
- Metastatic microsatellite stable colorectal cancer — a form of bowel cancer that has spread to other parts of the body and does not show microsatellite instability, a genetic feature that can influence how the cancer responds to treatment.
How is INCA33890 given?
In the Phase 3 trial, INCA33890 is given by intravenous infusion at a dose of 900 mg. The placebo arm contains the same formulation buffer without the active pharmaceutical ingredient. The standard-of-care chemotherapy in the trial includes fluorouracil, oxaliplatin and calcium folinate, all given by infusion or injection, together with bevacizumab.
What do the clinical trials show?
One clinical trial of INCA33890 is registered. It is a randomised, double-blind, Phase 3 study in metastatic microsatellite stable colorectal cancer. The trial is authorised but not yet recruiting participants. It plans to enrol 700 participants.
The trial compares standard-of-care chemotherapy and bevacizumab with or without INCA33890. Participants are randomly assigned to receive either INCA33890 plus standard therapy or placebo plus standard therapy. Neither the participants nor the researchers know which treatment each participant is receiving, which is what double-blind means.
What is the trial measuring?
The primary outcome is progression-free survival, defined as the time from randomisation to the first documented progression of the cancer, as determined by blinded independent central review according to RECIST v1.1 criteria, or death due to any cause. RECIST is a standard way of measuring how tumours respond to treatment.
Who can take part?
The trial enrols adults with metastatic microsatellite stable colorectal cancer who have not previously received treatment for their metastatic disease. The full eligibility criteria are available in the trial registry record.
What side effects are known?
The available registry data do not report side effects specific to INCA33890. Because the trial is not yet recruiting, no safety results from this study have been published. Side effects of the standard-of-care chemotherapy and bevacizumab used in the trial are described in their own product information.