Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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There is one clinical trial.
The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801.
Description: Incidence of dose limiting toxicities
Measure: Dose Limiting Toxicities (DLT) - dose escalation part Time: Up to 28 daysDescription: An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.
Measure: Safety and tolerability assessed by Adverse Events (AEs) Time: Up to 12 monthsDescription: Number of participants with potentially clinically significant laboratory values.
Measure: Number of participants with laboratory value abnormalities and/or adverse events Time: Up to 12 monthsDescription: Number of participants with potentially clinically significant vital sign values.
Measure: Number of participants with vital sign abnormalities and /or adverse events Time: Up to 12 monthsDescription: 12-lead ECGs will be read and assessed locally. Any clinically significant adverse changes on the ECG will be reported as Adverse Events.
Measure: Safety assessed by 12- lead electrocardiograms (ECGs) adverse events Time: Up to 12 monthsDescription: Percent change from baseline in sum of diameters of injected tumors per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and immune modified response evaluation criteria in solid tumors (imRECIST)
Measure: Percent change from baseline in antitumor activity of ASP9801 Time: Up to 12 monthsDescription: Partial Response (PR) + Complete Response (CR) per imRECIST
Measure: Objective Response Rate Time: Up to 12 monthsDescription: Viral DNA load will be summarized by cohort using descriptive statistics.
Measure: ASP9801 viral DNA in blood Time: Up to 12 monthsDescription: Viral DNA will be analyzed by quantitative polymerase chain reaction (qPCR).
Measure: Viral shedding of ASP9801 in saliva Time: Up to 12 monthsDescription: Viral DNA will be analyzed by qPCR.
Measure: Viral shedding of ASP9801 in urine Time: Up to 12 monthsDescription: Viral DNA will be analyzed by qPCR.
Measure: Viral shedding of ASP9801 in skin (cutaneous/subcutaneous only) Time: Up to 12 months