Actively Recruiting
Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors
Led by Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd · Updated on 2025-09-05
110
Participants Needed
2
Research Sites
182 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 with Olaparib in adult patients with locally advanced or metastatic solid tumors
CONDITIONS
Official Title
Study of SYN818 With Olaparib for the Treatment of Locally 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 confirmed diagnosis of advanced or metastatic solid tumor with BRCA mutations and/or homologous recombination repair deficiency (Part 1)
- Histologically or cytologically confirmed locally advanced or metastatic epithelial ovarian cancer or HER2-negative breast cancer with BRCA mutations and/or homologous recombination repair deficiency (Part 2)
- At least one measurable lesion according to RECIST v1.1
- No serious hematological, cardiopulmonary, liver, or kidney diseases other than the primary disease
- Adequate organ and bone marrow function
You will not qualify if you...
- Previous or current use of DNA Polymerase Theta (POLQ) inhibitors
- Current or previous other malignancy unless treated radically and no recurrence or metastasis within 5 years
- Central nervous system or meningeal metastasis with symptoms or uncontrolled disease
- Myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or features suggestive of these
- Dysphagia, refractory nausea/vomiting, malabsorption, biliary shunts, or gastrointestinal disorders affecting drug absorption
- Treatment with anti-cancer small molecule within 5 half-lives or 2 weeks, whichever is shorter
- Use or need to use protocol-prohibited strong inhibitors or inducers of cytochrome P450 3A4/BCRP/P-gp within 2 weeks before first dose or during study
- Serious systemic diseases, laboratory abnormalities, or other conditions making participation unsuitable as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Duo Wu
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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