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ASP9801Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Name (Synonyms) Correlation

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D009362 Neoplasm Metastasis NIH 0.58

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection in Patients With Advanced/Metastatic Solid Tumors

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.

NCT03954067 Metastatic Cancer Solid Tumors Advanced Cancer Biological: ASP9801
MeSH:Neoplasm Metastasis

Primary Outcomes

Description: Incidence of dose limiting toxicities

Measure: Dose Limiting Toxicities (DLT) - dose escalation part

Time: Up to 28 days

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Secondary Outcomes

Description: 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 months

Description: Partial Response (PR) + Complete Response (CR) per imRECIST

Measure: Objective Response Rate

Time: Up to 12 months

Description: Viral DNA load will be summarized by cohort using descriptive statistics.

Measure: ASP9801 viral DNA in blood

Time: Up to 12 months

Description: Viral DNA will be analyzed by quantitative polymerase chain reaction (qPCR).

Measure: Viral shedding of ASP9801 in saliva

Time: Up to 12 months

Description: Viral DNA will be analyzed by qPCR.

Measure: Viral shedding of ASP9801 in urine

Time: Up to 12 months

Description: Viral DNA will be analyzed by qPCR.

Measure: Viral shedding of ASP9801 in skin (cutaneous/subcutaneous only)

Time: Up to 12 months


No related HPO nodes (Using clinical trials)