A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

Launched by AVISTONE BIOTECHNOLOGY CO., LTD. · Mar 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ANS014004 in patients who have locally advanced or metastatic solid tumors, which means their cancer has either spread from where it started or cannot be fully removed by surgery. This is a Phase 1 study, which is the first time this drug is being tested in humans. The main goals are to see how safe the medication is, how well it is tolerated by participants, and to gather early information on how effective it might be against cancer.

To participate in the trial, individuals must be at least 18 years old and generally healthy, with a life expectancy of at least 12 weeks. They should have a specific type of cancer that shows changes in a gene called MET. However, people with active infections, untreated brain tumors, or serious heart and blood vessel diseases are not eligible for this study. Participants can expect regular health check-ups and monitoring while receiving the medication, helping researchers learn more about how ANS014004 works in treating cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
• • Life expectancy ≥ 12 weeks
• • Measurable disease per RECIST v1.1
• • Adequate organ and marrow function as defined in the protocol
• • With a pathogenetic MET alteration (including MET mutation, MET amplification, MET overexpression, MET fusion)
• Exclusion Criteria:
• • Active infection including tuberculosis and HBV, HCV or HIV
• • Known active or untreated CNS metastases
• • Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
• • Participants with serious cardiovascular or cerebrovascular diseases