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NCT Number: NCT06819215

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cancer Hospital of Shandong First Medical university

Jinan, Shandong, 250000, China

Location status: Recruiting

Location contact

Sun Yuping Chief physician, Doctor

CONTACT

[email protected]

China 86+13370582181

Yu Jinming Academicians of Chinese Academy of Engineering, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

VB15010

Drug

Oral PARP1 inhibitor

Primary outcomes

  1. The number of subjects with adverse events/serious adverse events

    Time frame: 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

  2. The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.

    Time frame: 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.

Secondary outcomes

  1. Maximum plasma concentration of the drug (Cmax)

    Time frame: 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)

  2. Objective Response Rate (prostate cancer)

    Time frame: From Screening to confirmed progressive disease (approximately 1 year)

    Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone)

Study contacts

Contact information is provided by the study sponsor or research team.

Song Jia Project manager, bachelor

CONTACT

[email protected]

China 86+18503817651

Zhang Nan Assistant project manager, bachelor

CONTACT

[email protected]

China 86+

Sponsors and collaborators

Lead sponsor

Zhejiang Yangli Pharmaceutical Technology Co., Ltd.

Industry

Collaborators

  • Shandong Cancer Hospital and Institute

Registry information

Official study title

Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Efficacy of VB15010 Tablets In Patients With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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