Clinical Trials in China / NCT06819215
Recruiting
Phase 1/2
Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors
NCT06819215 · tracked via the Priya Life Science China tracker
Condition(s) studied
CancerNeoplasmsNeoplasms, BreastTumorPARPOvarian NeoplasmsProstatic CancerPancreatic CancerBreast CancerBiliary CancerColorectal Cancer
Investigational drug(s) / intervention(s)
VB15010
VB15010: Oral PARP1 inhibitor
Study summary
This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Eligibility
Inclusion Criteria:
* Age ≥ 18 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;
* Homologous recombination repair gene mutation.
Exclusion Criteria:
* Major surgery within 4 weeks of the first dose of study treatment.
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \>10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
Primary outcome measure(s)
- The number of subjects with adverse events/serious adverse events — From time of Informed Consent to 30+7 days post last dose
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline - The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol. — At the end of Cycle 1(each cycle is 28 days)
A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer Hospital of Shandong First Medical university | Jinan | Shandong | Recruiting |
More Zhejiang Yangli Pharmaceutical Technology Co., Ltd. trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06819215 on ClinicalTrials.gov ↗ ← All trials in China