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

NCT06819215 | Recruiting Phase 1 DMC

• 1 other identifier: VB15010-001
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

VB15010; PARP; Ovarian cancer; Prostatic Cancer; Pancreatic cancer; Breast cancer; Biliary Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Maximum plasma concentration of the drug (Cmax)

  At predefined intervals throughout the treatment period (through study completion, an everage of 1 year)

• Objective Response Rate (prostate cancer)

  From Screening to confirmed progressive disease (approximately 1 year)

Study Arms (1)

Experimental

EXPERIMENTAL

VB15010 Monotherapy

Drug: VB15010

Interventions

VB15010 DRUG

Oral PARP1 inhibitor

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zhejiang Yangli Pharmaceutical Technology Co., Ltd.: lead
• Shandong Cancer Hospital and Institute: collaborator

Study Sites (1)

Cancer Hospital of Shandong First Medical university

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases; Biliary Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Song Jia Project manager, bachelor

CONTACT

China 86+18503817651; songjia@vybio.com

Zhang Nan Assistant project manager, bachelor

CONTACT

China 86+; zhangnan@vybio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 11, 2025
• Study Start: October 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)