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

Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of 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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Cancer; Breast Cancer; Colorectal Cancer; Pancreatic Cancer; Ovarian Neoplasms; Tumor; Neoplasms, Breast; Prostatic Cancer; Biliary Cancer; PARP
• Intervention / Treatment: Drug: VB15010

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Phase 2; Phase 1

Contacts and Locations

• 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

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Cancer Hospital of Shandong First Medical University
      • Contact: Sun Yuping Chief physician, Doctor; Phone Number: China 86+13370582181; Email: 13370582181@163.com
      • Contact: Yu Jinming Academicians of Chinese Academy of Engineering, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; VB15010 Monotherapy	Drug: VB15010; Oral PARP1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Shenzhen Yangli Pharmaceutical Technology Co., Ltd
• Collaborators: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Ovarian cancer; Pancreatic cancer; Biliary Cancer; PARP; Prostatic Cancer; VB15010
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Pancreatic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Neoplasms; Prostatic Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: VB15010-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No