Actively Recruiting
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors
Led by Avistone Biotechnology Co., Ltd. · Updated on 2026-04-17
63
Participants Needed
15
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ANS014004 in adults with locally advanced or metastatic solid tumors in this Phase 1, first-in-human, open-label, multi-center study. The study aims to explore the safety, tolerability, how the drug moves through the body, and preliminary anti-tumor activity of ANS014004 when used alone. This early-phase research is important to understand how the drug behaves and its potential effects on tumors in patients with these advanced cancers. The study has two parts. Part 1 focuses on determining the safety, tolerability, and the best dose for future studies by gradually increasing the dose of ANS014004. Part 2 will further evaluate safety and assess anti-tumor activity of ANS014004 as a single treatment in selected solid tumors. Participants will receive varying doses of ANS014004 during these parts, with careful monitoring throughout. Participants will be closely observed from the first dose through 28 days after the last dose for side effects, laboratory tests, heart function, and vital signs. Researchers will also monitor tumor response using imaging over about two years or until disease progression. Additional assessments include measuring how the drug is processed in the body. The study ensures participant safety with regular evaluations and aims to gather detailed information on the drug's effects and tolerability over time.
CONDITIONS
Brief Title
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Measurable disease according to RECIST v1.1
- Adequate organ and marrow function as defined in the protocol
- Presence of pathogenic MET, ROS1, or NTRK genetic alterations
You will not qualify if you...
- Active infection including tuberculosis, hepatitis B or C, or HIV
- Known active or untreated central nervous system metastases
- Carcinomatous meningitis, meningeal metastases, or spinal cord compression
- Serious cardiovascular or cerebrovascular diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From first dose until disease progression or treatment discontinuation (up to approximately 2 years)
Participants receive varying doses of ANS014004 as monotherapy to evaluate safety, tolerability, and preliminary efficacy in locally advanced or metastatic solid tumors.
Regular visits during treatment period as per protocol
Duration - 28 days post last dose
Participants are monitored for safety and treatment outcomes after the last dose of ANS014004.
Approximately 1 follow-up visit
Trial Site Locations
Total: 15 locations
1
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
Sarah Cannon Research Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
Advent Health
Orlando, Florida, United States, 32804
Actively Recruiting
4
Henry Ford Health Cancer
Detroit, Michigan, United States, 48202
Actively Recruiting
5
NYU Langone Health
New York, New York, United States, 10003
Actively Recruiting
6
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
NEXT Oncology, Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
8
Swedish Cancer Institute
Seattle, Washington, United States, 98195
Actively Recruiting
9
BC Cancer Vancouver Centre
Vancouver, British Columbia, Canada
Actively Recruiting
10
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Actively Recruiting
11
Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101149
Not Yet Recruiting
12
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150010
Not Yet Recruiting
13
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
14
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
15
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
Research Team
A
Avistone Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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