Actively Recruiting
Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors
Led by Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd · Updated on 2025-07-20
30
Participants Needed
2
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors
CONDITIONS
Official Title
Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the written Informed Consent Form (ICF)
- Male or female aged 18 years or older
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
- Histologically or cytologically confirmed locally advanced or metastatic breast, ovarian, prostate cancer, or other advanced solid tumors with disease progression and exhausted standard therapies
- Willing to provide tumor tissue samples or blood samples to detect BRCA mutation or homologous recombination repair deficiency via next generation sequencing
- At least one measurable lesion according to RECIST v1.1
- No serious hematological, cardiopulmonary, liver, or kidney diseases other than the primary cancer
- Adequate organ and bone marrow function
You will not qualify if you...
- Previous or current use of POLQ inhibitors
- Hypersensitivity to SYN818 or any excipients
- Central nervous system metastasis or meningeal metastasis with clinical symptoms or uncontrolled CNS involvement
- Other malignant tumors within 5 years prior to first dose except for certain localized cancers cured or disease-free for at least 3 years
- Diagnosis of Myelodysplastic syndrome or Acute myeloid leukemia or features suggestive of these
- Conditions affecting drug absorption such as dysphagia, refractory nausea/vomiting, malabsorption, Crohn's disease, ulcerative colitis, short bowel syndrome, or extracorporeal biliary shunts
- Major surgery or serious trauma within 4 weeks prior to first dose or planned surgery during trial with unresolved related adverse events
- Use or need to use potent inhibitors or inducers of CYP3A4/BCRP/P-gp within 2 weeks prior to first dose or during the study
- Serious systemic diseases, laboratory abnormalities, or other conditions making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
2
Fudan University Shanghai Cancer Center.
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
T
Tongfu Xu, PHD
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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