Phase I/II Clinical Study To Evaluate VB15010 Tablets In Patients With Advanced Solid Tumors

Study Overview

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

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.

N/A

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

DRUG: VB15010

VB15010-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-01-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-04
First Submitted that Met QC Criteria 2025-02-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-11
First Posted (ACTUAL) 2025-02-11	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental VB15010 Monotherapy	DRUG: VB15010 Oral PARP1 inhibitor

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental

VB15010 Monotherapy

DRUG: VB15010

Oral PARP1 inhibitor

Primary Outcome Measures	Measure Description	Time Frame
The number of subjects with adverse events/serious adverse events	Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline	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.	A DLT is defined as any toxicity that occurs from the ﬁrst dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.	At the end of Cycle 1(each cycle is 28 days)

Secondary Outcome Measures	Measure Description	Time Frame
Maximum plasma concentration of the drug (Cmax)	The concentration of VB15010 in plasma will be determined (Cmax will be derived)	At predefined intervals throughout the treatment period (through study completion, an everage of 1 year)
Objective Response Rate (prostate cancer)	Best response until progression, as deﬁned by RECIST 1.1 or PCWG3 (bone)	From Screening to conﬁrmed progressive disease (approximately 1 year)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Song Jia Project manager, bachelor

Phone Number: China 86+18503817651

Email: songjia@vybio.com

Study Contact Backup

Name: Zhang Nan Assistant project manager, bachelor

Phone Number: China 86+

Email: zhangnan@vybio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Shandong Cancer Hospital and Institute

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record