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

NCT ID: NCT06819215

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2026-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

VB15010 Monotherapy

Group Type EXPERIMENTAL

VB15010

Intervention Type DRUG

Oral PARP1 inhibitor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VB15010

Oral PARP1 inhibitor

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role collaborator

Zhejiang Yangli Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cancer Hospital of Shandong First Medical university

Jinan, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Song Jia Project manager, bachelor

Role: CONTACT

China 86+18503817651

Zhang Nan Assistant project manager, bachelor

Role: CONTACT

China 86+

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sun Yuping Chief physician, Doctor

Role: primary

China 86+13370582181

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VB15010-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

First Line Chemotherapy for Advanced Cancer
NCT01980810 TERMINATED PHASE2