Actively Recruiting
Phase I Study Evaluating SYN818 as Oral Monotherapy for Locally 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SYN818, a DNA Polymerase Theta (POLQ) inhibitor, as a treatment for adults with locally advanced or metastatic solid tumors, including breast, ovarian, and prostate cancers. This Phase I, open-label, multicenter study aims to assess the safety, tolerability, how the body processes the drug, its effects on the body, and preliminary anti-tumor activity. The study is sponsored by Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd and focuses on patients who have progressed despite standard therapies. Participants will receive SYN818 orally as a tablet monotherapy. The treatment is given in cycles lasting 21 days, with ongoing monitoring to identify the maximum tolerated dose and any dose-limiting toxicities. The study involves up to three years of follow-up to assess safety, pharmacokinetics, pharmacodynamics, and tumor response. Patients must provide tumor tissue or blood samples for genetic testing related to BRCA mutation or homologous recombination repair deficiency. During the study, participants will undergo regular evaluations including scans for measurable lesions, blood tests to monitor tumor markers like CA125 and PSA, and monitoring for adverse events. Researchers will track how long responses last, time to response, and progression-free survival. Safety is monitored from consent through 30 days post-treatment, with toxicity assessments during the first treatment cycle. The total follow-up can last up to three years to observe long-term effects and outcomes.
CONDITIONS
Brief Title
Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form
- 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
- Willingness to provide tumor tissue or blood samples for BRCA mutation or homologous recombination repair deficiency testing
- At least one measurable lesion according to RECIST v1.1
- No serious hematological, cardiopulmonary, liver, or kidney diseases other than primary disease
- Adequate organ and bone marrow function
You will not qualify if you...
- Previous or current use of POLQ inhibitors
- Hypersensitivity to SYN818 or its excipients
- Central nervous system metastasis or meningeal metastasis with clinical symptoms or uncontrolled CNS disease
- Other malignant tumors within 5 years prior to first dose except certain localized, cured cancers
- History or features of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML)
- Gastrointestinal disorders affecting drug absorption such as Crohn's disease or ulcerative colitis
- Major surgery or serious trauma within 4 weeks prior to first dose or planned during trial with unresolved related adverse events
- Use of potent inhibitors or inducers of cytochrome P450 3A4/BCRP/P-gp within 2 weeks prior to first dose
- Serious systemic diseases or laboratory abnormalities making participation unsuitable as per investigator judgment
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 - Repeated 21-day cycles until disease progression or discontinuation.
Participants receive oral SYN818 as monotherapy for their advanced or metastatic solid tumors.
Visits occur as needed for dosing and safety monitoring during treatment cycles
Duration - Up to 3 years
Participants are monitored for adverse events and treatment outcomes after stopping SYN818.
Visits occur periodically up to 30 days post last dose and long-term follow-up assessments up to 3 years
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
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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