In short
ATX-898 is an investigational oral substance being studied in a first-in-human trial for advanced solid tumors. The authorised Phase 1/2 trial (EU CT number 2026-526514-85-00) plans to enrol 309 participants and tests ATX-898 alone and in combination with other anti-cancer medicines. The study measures safety, tolerability, and early signs of antitumor activity.
Key points
- ATX-898 is an investigational oral substance with no marketing authorisation in these records.
- The single registered trial is a Phase 1/2 first-in-human study in advanced solid tumors.
- The trial plans to enrol 309 participants and is currently authorised.
- ATX-898 is tested as monotherapy and in combination with fulvestrant plus abemaciclib or ribociclib.
- Key measures include dose-limiting toxicities, recommended dose for expansion, and objective response rate.
What is ATX-898?
ATX-898 is an investigational substance with no marketing authorisation in the registry records provided. It is being developed as an oral therapy for people with advanced solid tumors. The substance is studied in oncology, the area of medicine concerned with cancer. In the trial record, ATX-898 appears as the test substance, meaning the trial investigates this substance directly.
How does ATX-898 work?
The registry data provided does not describe a molecular target or mechanism of action for ATX-898. The trial is a first-in-human study, which means ATX-898 has not been tested in people before. The study design includes combination arms with fulvestrant, abemaciclib, and ribociclib, which are medicines used in hormone receptor-positive breast cancer, but the trial population is broader: participants with advanced solid tumors.
Which conditions is ATX-898 studied for?
- Advanced solid tumors — cancers that form solid masses and have spread or cannot be removed by surgery. The trial includes participants with various types of advanced solid tumors.
How is ATX-898 given?
ATX-898 is given by mouth (orally). The trial record lists ATX-898 as an oral drug in two separate intervention entries, suggesting different dose levels or schedules are being tested. The combination partners in the trial include oral tablets (abemaciclib 50 mg, ribociclib 200 mg) and an intramuscular injection (fulvestrant 250 mg/5 ml).
What do the clinical trials show?
The clinical development of ATX-898 consists of one authorised Phase 1/2 trial with a planned enrolment of 309 participants. The study is divided into four parts. Part 1A evaluates the safety and tolerability of ATX-898 as monotherapy and determines the maximum tolerated dose (MTD) or maximum tested dose and the recommended dose for expansion (RDE). Part 1B assesses antitumor activity of ATX-898 monotherapy in expansion cohorts. Part 2A determines the RDE of ATX-898 in combination with fulvestrant and abemaciclib, or fulvestrant and ribociclib. Part 2B further assesses antitumor activity at the combination RDE.
The trial measures dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and grade 3 or higher laboratory abnormalities. It also measures the objective response rate (ORR), defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
The trial status is authorised, meaning the trial has received regulatory approval to proceed but may not yet be recruiting participants. Participants are adults with advanced solid tumors. The trial excludes no specific tumor type in the registry record, so the population is broad across solid tumor types.
What side effects are known?
The registry record does not report side effects for ATX-898. Because this is a first-in-human study, side effects are not yet known. The trial itself is designed to identify dose-limiting toxicities and adverse events as its primary objective.