Actively Recruiting
A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors
Led by Ascentawits Pharmaceuticals, Ltd · Updated on 2024-02-07
180
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of AST-001 administered as a single agent.
CONDITIONS
Official Title
A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand study risks and willing to follow protocol with signed consent
- Aged 18 to 70 years, male or female
- Histologically or cytologically confirmed metastatic or unresectable solid malignancy with no effective standard treatment
- ECOG performance status of 0 or 1
- Expected life expectancy of at least 12 weeks
- Recovered from prior therapy side effects to Grade 0 or 1
- Adequate kidney, liver, and bone marrow function
- For phase II pancreatic cancer: at least one measurable lesion meeting RECIST 1.1 criteria
- For phase II pancreatic cancer: able to provide pathological samples confirming strong AKR1C3 expression
You will not qualify if you...
- Another primary cancer within 2 years except treated basaloma, in situ cancer, or non-interfering cancers
- Major surgery (other than diagnostic) within 4 weeks before study start
- Radiation, chemotherapy, biotherapy, targeted therapy, or hormone treatment within 4 weeks before study start
- Participation in other investigational therapy within 4 weeks before study start
- Use of repaglinide or certain CYP enzyme inhibitors/inducers
- Pleural effusion or ascites requiring frequent drainage (every other week or more)
- Hepatitis B virus infection with high viral load (HBV-DNA ≥ 2,000 IU/mL)
- Active uncontrolled infections needing systemic treatment
- History of HIV or syphilis infection
- Certain heart conditions including severe heart failure, prolonged QTcF interval, recent myocardial infarction or surgery, or other unsuitable cardiac disease
- Pregnant or breastfeeding females
- Any condition or disease that could interfere with study conduct or pose unacceptable risk
- Allergy to ethanol, polyoxyethylene (35) castor oil, or N,N-dimethylacetamide
- Unwillingness or inability to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jinlin Cancer Hospital
Changchun, Jinlin, China, 130000
Actively Recruiting
Research Team
C
Claire Hao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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