Actively Recruiting
Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Efficacy of VB15010 Tablets In Patients With Advanced Solid Tumors
Led by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. · Updated on 2025-02-11
188
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
Lead Sponsor
S
Shandong Cancer Hospital and Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying an experimental drug called VB15010, a PARP1 inhibitor, to see if it is safe, tolerable, and has anti-cancer effects in patients with advanced solid tumors. This phase I/II clinical trial focuses on adults aged 18 to 75 who have progressive cancer confirmed by tissue tests and specific gene mutations related to DNA repair. Participants will receive VB15010 tablets as a monotherapy. This oral drug is given in cycles of 28 days, and researchers will carefully monitor the safety, side effects, and the drug's behavior in the body. The study will track dose-limiting toxicities during the first cycle and observe the drug's maximum blood concentration over about one year. The trial includes patients with various advanced cancers, including breast, prostate, ovarian, pancreatic, biliary, and colorectal cancers. During the study, participants will undergo evaluations for adverse events and serious side effects from the time they consent until 30 days after their last dose. Researchers will also assess tumor response in prostate cancer patients and monitor pharmacokinetics and pharmacodynamics throughout treatment. The total participation time and follow-up will vary depending on individual response, with safety and efficacy measured regularly. The trial is sponsored by Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
CONDITIONS
Brief Title
Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of screening
- Histological or cytological confirmation of advanced malignancy
- Progressive cancer at the time of study entry
- Adequate organ and marrow function as defined by the protocol
- Presence of homologous recombination repair gene mutation
You will not qualify if you...
- Major surgery within 4 weeks before the first dose of study treatment
- Spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not requiring continuous corticosteroids over 10 mg prednisone daily for at least 4 weeks prior
- Patients with leptomeningeal carcinomatosis
- Diagnosis of myelodysplastic syndrome or acute myeloid leukemia, or features suggesting these conditions
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.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive VB15010 tablets as a monotherapy to evaluate safety, tolerability, and preliminary efficacy.
Duration - 30+7 days post last dose
Participants are monitored for safety and adverse events after the last dose of study treatment.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical university
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
S
Song Jia Project manager, bachelor
Z
Zhang Nan Assistant project manager, bachelor
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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