Actively Recruiting
A Phase 1 Study of YZJ-5053 Tablets in Participants With Advanced Solid Tumors
Led by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Updated on 2024-01-17
157
Participants Needed
4
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of YZJ-5053 Tablets in Participants with Advanced Solid Tumors
CONDITIONS
Official Title
A Phase 1 Study of YZJ-5053 Tablets in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- Histologically or cytologically confirmed advanced or metastatic solid tumors with no effective standard treatment or ineligible for standard treatment
- At least one measurable or evaluable tumor lesion according to study phase
- Clinically stable brain metastases without symptoms and no steroid therapy for at least 4 weeks before treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate blood counts and organ function as defined by specific laboratory criteria within 28 days prior to treatment
- Negative pregnancy test for women of child-bearing potential before starting treatment
- Agreement to use effective contraception before, during, and for at least 28 days after treatment
You will not qualify if you...
- Pregnant or breastfeeding women
- History of other malignancies within 3 years except certain treated cancers without evidence of disease
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Significant heart problems or cardiovascular disease
- Gastrointestinal conditions that affect absorption of the study drug
- Active infections needing intravenous antibiotics at screening or within 2 weeks before treatment
- Positive HIV, active hepatitis B or C infections
- Recent chemotherapy within 3 weeks or other anti-tumor therapies within 4 weeks before treatment
- Inability to stop certain medications affecting liver enzymes during the study
- Recent live vaccine within 4 weeks before treatment
- Prior use of specific receptor antagonists related to the study drug
- Ongoing adverse effects from previous cancer treatments not resolved to mild or baseline levels
- Certain autoimmune diseases or use of systemic immunosuppressants or corticosteroids within 4 weeks before treatment
- Major surgery within 4 weeks before treatment or planned during the study
- Other severe or uncontrolled medical conditions or laboratory abnormalities that could affect safety or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
2
Shandong Cancer Hospital
Jinan, Shandong, China, 250000
Not Yet Recruiting
3
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
4
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
Research Team
Y
Yan Shi
CONTACT
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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