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Recruiting NCT06819215

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

Phase I / Phase II Interventional Cancer Neoplasms Neoplasms, Breast Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VB15010.
Who it may be relevant to
Registry conditions: Cancer, Neoplasms, Neoplasms, Breast, Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug VB15010
    Oral PARP1 inhibitor

Primary outcome measures

  • The number of subjects with adverse events/serious adverse events [Time frame: From time of Informed Consent to 30+7 days post last dose]
  • The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol. [Time frame: At the end of Cycle 1(each cycle is 28 days)]
Secondary outcome measures (2)
  • Maximum plasma concentration of the drug (Cmax) [Time frame: At predefined intervals throughout the treatment period (through study completion, an everage of 1 year)]
  • Objective Response Rate (prostate cancer) [Time frame: From Screening to confirmed progressive disease (approximately 1 year)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital of Shandong First Medical university — Jinan

Identifiers

NCT: NCT06819215 · VB15010-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗