A Study of ABSK-011 for Advanced Solid Tumors
This study is testing a new oral drug called ABSK-011 for people with advanced solid tumors, including advanced liver cancer. The main goals are to understand how safe ABSK-011 is, how well your body handles it (tolerability), and how it moves through your body (pharmacokinetics). Researchers will also look for the highest safe dose and see if it has any effect on tumors. You may be able to join if you are between 18 and 75 years old and have advanced solid tumors that have progressed despite standard treatments, or if no standard treatment options are available. The study is currently unclear on its recruitment status.
- Study design
- This is an open-label, Phase 1 study, meaning both you and your doctors will know you are receiving ABSK-011. It plans to enroll 200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 30 days after your last dose, which is expected to be about six months after starting the study drug. Dose adjustments or discontinuation will be tracked throughout the study, also for about six months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor
At a glance
Conditions
Where it's being run
32 sites across 25 statesStudy leadership
- Xiaoping Chen, Doctor · PRINCIPAL_INVESTIGATOR · Tongji Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of DLTFrom the starting dosing of study drug to the end of Cycle 1 (each cycle is 28 days) in escalation Part
Incidence of dose-limiting toxicities (DLTs) in Cycle 1
- Incidence and severity of AEs, AESIs and SAEs30 days after last administration, an average of one half year
Incidence and severity of adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs) (Common Terminology Criteria for Adverse Events, CTCAE 5.0)
- dose reduction or discontinuationthrough study completion, an average of one half year
dose reduction or discontinuation of study drug due to toxicity
- physical examinations changes from baselinethrough study completion, an average of one half year
BMI
- ECOG performance statusthrough study completion, an average of one half year
ECOG performance status
- electrocardiograms (ECGs)through study completion, an average of one half year
QTc
- echocardiograms changes from baselinethrough study completion, an average of one half year
EF%
- vital signs changes from baselinethrough study completion, an average of one half year
Temperature
- vital signs changes from baselinethrough study completion, an average of one half year
pulse
- vital signs changes from baselinethrough study completion, an average of one half year
blood pressure