Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors
Recruiting · NCT06819215 · Interventional (participants receive a specific treatment) · Lead sponsor: Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
VB15010
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
2 locations listed.
- Cancer Hospital of Shandong First Medical university - Jinan, Shandong, China
- Cancer Hospital of Shandong First Medical university - Jinan, Shandong, China