A Study of ANS014004 for Advanced Solid Tumors
This study is testing a drug called ANS014004 in people with locally advanced or metastatic (spread to other parts of the body) solid tumors. The main goal is to see how safe ANS014004 is and what side effects it might cause. Researchers will also look at how the drug moves through the body and if it shows any early signs of helping to treat the cancer. You might be able to join if you are at least 18 years old, have a good general health status, and your tumor has specific changes in the MET, NTRK, or ROS1 genes. The study is open to both men and women.
- Study design
- This is a Phase 1, first-in-human study, meaning it's one of the first times this drug is being tested in people. It is an open-label study, so both you and your doctors will know you are receiving ANS014004. The study plans to enroll about 63 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the time of your first dose to 28 days after your last dose of ANS014004.
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 Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
At a glance
Conditions
Where it's being run
15 sites across 15 statesStudy leadership
- Medical Director Clinical Science · STUDY_DIRECTOR · Beijing Avistone Biotechnology Co., Ltd.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of Adverse Events (AEs)From the time of first dose to 28 days post last dose of ANS014004
Number of patients with adverse events by system organ class and preferred term
- Incidence of Serious Adverse Events (SAEs)From time of first dose to 28 days post last dose of ANS014004
Number of patients with serious adverse events by system organ class and preferred term
- Incidence of dose-limiting toxicities (DLT) as defined in the protocolFrom time of first dose of ANS014004 to end of DLT period (approximately 30 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
- Incidence of baseline laboratory finding, ECG and vital signs changesFrom time of first dose to 28 days post last dose of ANS014004
measured by laboratory and vital sign variables over time including change from
- Proportion of patients with radiological response (ORR)From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1