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

RECRUITINGPhase 1/2Sponsored by Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
Actively Recruiting
PhasePhase 1/2
SponsorZhejiang Yangli Pharmaceutical Technology Co., Ltd.
Started2024-10-30
Est. completion2025-12-30
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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).

Conditions11

Biliary CancerBreast CancerCancerColorectal CancerNeoplasmsNeoplasms, BreastOvarian NeoplasmsPARPPancreatic CancerProstatic Cancer

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