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Trial Title:
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT06307795
Condition:
Locally Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ANS014004
Description:
Varying doses of ANS014004
Arm group label:
ANS014004 Monotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
MD
Facility:
Name:
Advent Health
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
The University of Texas - MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
NEXT Oncology, Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Univ. of Washington Medical Center
Address:
City:
Seattle
Zip:
98109-1024
Country:
United States
Status:
Not yet recruiting
Start date:
April 20, 2024
Completion date:
October 2027
Lead sponsor:
Agency:
Avistone Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Avistone Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06307795
