Evaluating VB15010 Tablets for 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
PHASE1; PHASE2 · Zhejiang Yangli Pharmaceutical Technology Co., Ltd. · NCT06819215
This study is testing a new tablet called VB15010 to see if it can help people with advanced solid tumors and specific genetic mutations feel better and fight their cancer.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang Yangli Pharmaceutical Technology Co., Ltd. (industry) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06819215 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, and anti-cancer activity of VB15010, a PARP1 inhibitor, in patients with advanced solid tumors. The study includes patients with confirmed advanced malignancies who have progressive cancer and specific genetic mutations related to homologous recombination repair. Participants will receive the experimental treatment and be monitored for its effects and side effects. The trial is designed to gather data that could inform future treatment options for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with advanced malignancies and specific genetic mutations.
Not a fit: Patients with recent major surgeries, symptomatic brain metastases, or certain blood disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors, potentially improving their outcomes.
How similar studies have performed: Other studies involving PARP inhibitors have shown promise in treating various cancers, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Jinan, Shandong
- Cancer Hospital of Shandong First Medical university — Jinan, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Song Jia Project manager, bachelor
- Email: songjia@vybio.com
- Phone: China 86+18503817651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Neoplasms, Neoplasms, Breast, Tumor, PARP, Ovarian Neoplasms, Prostatic Cancer, Pancreatic Cancer