RecruitingPhase 1Phase 2NCT06819215

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

Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Efficacy of VB15010 Tablets In Patients With Advanced Solid Tumors

Sponsor

Zhejiang Yangli Pharmaceutical Technology Co., Ltd.

Enrollment

188 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Pancreatic Cancer Cancer Ovarian Neoplasms Neoplasms Neoplasms, Breast Tumor PARP Prostatic Cancer Biliary Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria3

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).