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

Phase 1

Recruiting

• Conditions: PARP; Neoplasms; Pancreatic Cancer; Tumor; Biliary Cancer; Neoplasms, Breast; Prostatic Cancer; Breast Cancer; Colorectal Cancer; Cancer
• Interventions: Drug: VB15010

• Registration Number: NCT06819215
• Lead Sponsor: Shenzhen Yangli Pharmaceutical Technology Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-12-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	VB15010	VB15010 Monotherapy

Primary Outcome Measures

Name	Time	Method
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.	At the end of Cycle 1(each cycle is 28 days)	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.
The number of subjects with adverse events/serious adverse events	From time of Informed Consent to 30+7 days post last dose	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Hospital of Shandong First Medical university; 🇨🇳 Jinan, Shandong, China