NCT06307795 A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT06307795 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Avistone Biotechnology Co., Ltd. |
| Condition | Locally Advanced or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 63 participants in total. It began in 2024-06-24 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.
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 or ROS1 alteration or NTRK alternation 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
Contact & Investigator
Medical Director Clinical Science
STUDY DIRECTOR
Beijing Avistone Biotechnology Co., Ltd.
Frequently Asked Questions
Who can join the NCT06307795 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06307795 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06307795 currently recruiting?
Yes, NCT06307795 is actively recruiting participants. Contact the research team at information.center@avistonebio.com for enrollment information.
Where is the NCT06307795 trial being conducted?
This trial is being conducted at San Diego, United States, Denver, United States, Orlando, United States, Detroit, United States and 11 additional locations.
Who is sponsoring the NCT06307795 clinical trial?
NCT06307795 is sponsored by Avistone Biotechnology Co., Ltd.. The principal investigator is Medical Director Clinical Science at Beijing Avistone Biotechnology Co., Ltd.. The trial plans to enroll 63 participants.