CancerPhase 1/2NCT06819215
Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors
A Phase 1/2 study testing VB15010 in people with Cancer and Neoplasms, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer, Neoplasms, Neoplasms, Breast
- What is being tested?
- VB15010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Shandong First Medical university
Jinan, Shandong, 250000
Sun Yuping Chief physician, Doctor, China 86+13370582181, 13370582181@163.com
Yu Jinming Academicians of Chinese Academy of Engineering, Doctor
About this study
Official 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
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
- Being tested
- VB15010
- Keywords
- VB15010, PARP, Ovarian cancer, Prostatic Cancer, Pancreatic cancer, Breast cancer, Biliary Cancer
- Medical subject headings
- Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB15010Drug
Oral PARP1 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | VB15010 Monotherapy Receives: Drug: VB15010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At the end of Cycle 1(each cycle is 28 days)
Secondary outcomes (2)
Maximum plasma concentration of the drug (Cmax)
The concentration of VB15010 in plasma will be determined (Cmax will be derived)
Measured: 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)
Measured: From Screening to confirmed progressive disease (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start30 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shandong Cancer Hospital and Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819215
- Sponsor's protocol ID
- VB15010-001
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06819215
- Acronym / sponsor ID
- VB15010-001
- Conditions
- Cancer, Neoplasms, Neoplasms, Breast, Tumor, PARP, Ovarian Neoplasms
- Keywords
- VB15010, PARP, Ovarian cancer, Prostatic Cancer, Pancreatic cancer, Breast cancer, Biliary Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shandong Cancer Hospital and Institute
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: VB15010VB15010 Monotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB15010Oral PARP1 inhibitor | Drug | Experimental |
Primary outcome
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
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.
2 secondary outcomes
Maximum plasma concentration of the drug (Cmax)
Time frame: At predefined intervals throughout the treatment period (through study completion, an everage of 1 year)
Objective Response Rate (prostate cancer)
Time frame: From Screening to confirmed progressive disease (approximately 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VB15010 in people with Cancer and Neoplasms, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Jia Project manager, bachelor (China 86+18503817651, songjia@vybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with adverse events/serious adverse events (time frame: From time of Informed Consent to 30+7 days post last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.