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| Name | Class |
|---|---|
| Shandong Cancer Hospital and Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | VB15010 Monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB15010 | Drug | Oral PARP1 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of the drug (Cmax) | The concentration of VB15010 in plasma will be determined (Cmax will be derived) | At predefined intervals throughout the treatment period (through study completion, an everage of 1 year) |
| Objective Response Rate (prostate cancer) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Jia Project manager, bachelor | Contact | China 86+18503817651 | songjia@vybio.com | |
| Zhang Nan Assistant project manager, bachelor | Contact | China 86+ | zhangnan@vybio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Shandong First Medical university | Recruiting | Jinan | Shandong | 250000 | China |
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Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone) |
| From Screening to confirmed progressive disease (approximately 1 year) |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D001660 | Biliary Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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