A Phase 1/2 interventional study of VB15010 in Cancer, Neoplasms and Neoplasms, Breast, sponsored by Zhejiang Yangli Pharmaceutical Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 188 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Zhejiang Yangli Pharmaceutical Technology Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
VB15010 Monotherapy
Drug: VB15010
Oral PARP1 inhibitor
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
Time frame: 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.
Time frame: At the end of Cycle 1(each cycle is 28 days)
Maximum plasma concentration of the drug (Cmax)
The concentration of VB15010 in plasma will be determined (Cmax will be derived)
Time frame: 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)
Time frame: From Screening to confirmed progressive disease (approximately 1 year)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2025, 14 months after the start.
Of 297 industry-sponsored phase 1/2 interventional studies under Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 84. This study's planned 14 months is below that.
Counting every sponsor, half of 417 studies reached it within 59 months; a quarter within 36 and three quarters within 84.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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Zhejiang Yangli Pharmaceutical Technology Co., Ltd.