Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Yangli Pharmaceutical Technology Co., Ltd.

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • VB15010

Treatment groups

188 Participants
are divided into 1 treatment group

Sponsors and collaborators

Zhejiang Yangli Pharmaceutical Technology Co., Ltd.

Lead sponsor

Shandong Cancer Hospital and Institute

Collaborator