Study of ANS03 for Advanced Solid Tumors with ROS1 or NTRK Alterations
This study is testing a new drug called ANS03 in people with locally advanced or metastatic (spread to other parts of the body) solid tumors. To join, your tumor must have a specific genetic change called a ROS1 or NTRK alteration. ANS03 is designed to target these specific changes. The main goals are to see how safe ANS03 is, how well your body tolerates it, and if it shows any early signs of shrinking tumors. Researchers will also look at how the drug moves through your body. This is a "first-in-human" study, meaning it's one of the first times ANS03 is being given to people. The study plans to enroll 96 participants. The current status of the study is unclear.
- Study design
- This is a Phase 1, multi-center, open-label study, meaning both you and the study team will know you are receiving ANS03. It is a single-arm study, so all participants will receive ANS03. The study plans to enroll 96 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored from the first dose to 28 days after your last dose of ANS03. Dose-limiting toxicities will be assessed for approximately 30 days after the first dose.
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 ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
At a glance
Conditions
Where it's being run
5 sites across 5 statesWho 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 ANS03
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 ANS03
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 ANS03 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 ANS03
measured by laboratory and vital sign variables over time including change from baseline
- Proportion of patients with radiological response (ORR)From date of first dose of ANS03 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