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Virus Therapy

ASP9801 + Pembrolizumab for Cancer

Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have histologically- or cytologically-confirmed diagnosis of advanced or metastatic solid tumor(s).
Subject must have histologically- or cytologically-confirmed diagnosis of advanced or metastatic solid tumor(s).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, ASP9801, to see if it is safe and effective. The trial will also study how well the drug works when combined with another cancer drug, pembrolizumab.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors who have tried all other treatments without success. They must be expected to live at least 12 weeks, agree to use contraception, and not donate eggs or sperm. Participants need measurable disease suitable for injection and biopsy, an ECOG performance status of 0 or 1, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests the safety and ideal dose of ASP9801 alone and combined with pembrolizumab (an immune checkpoint inhibitor). It will look at how well these treatments shrink tumors, their effects on the body over time, virus shedding from the tumor site, and overall response rates in patients.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immune therapies such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, changes in blood counts leading to increased infection risk or bleeding tendencies. Specific side effects from ASP9801 are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed to be advanced or has spread to other parts of my body.
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My cancer is confirmed to be advanced or has spread to other parts.
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I have a tumor that can be measured and is the right size for a specific injection.
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I agree not to breastfeed during and for 180 days after the study ends.
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My condition worsened after treatment, or I can't tolerate/have refused all known beneficial therapies.
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I have a tumor that can be measured and is the right size for a direct injection.
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I am fully active or can carry out light work.
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I agree to use contraception or remain abstinent for 6 months after the last study treatment.
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I will not donate eggs during and for 6 months after the study ends.
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I am willing to have at least 2 tumor biopsies as per my hospital's rules.
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I am fully active or can carry out light work.
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My condition worsened after treatment, or I couldn't tolerate or refused all known beneficial therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicities (DLT) - dose escalation part
Number of participants with laboratory value abnormalities and/or adverse events
Number of participants with vital sign abnormalities and /or adverse events
+2 more
Secondary outcome measures
ASP9801 viral DNA in blood
Change in Programmed Cell Death Ligand 1 (PD-L1) Expression in Tumor
Objective Response Rate per Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1
+5 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Dose Expansion (Monotherapy) - visceral lesionsExperimental Treatment1 Intervention
Participants will receive ASP9801 on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met.
Group II: Dose Expansion (Monotherapy) - cutaneous or subcutaneous lesionsExperimental Treatment1 Intervention
Participants will receive ASP9801 on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met.
Group III: Dose Expansion (Monotherapy Induction) - cutaneous or subcutaneous lesionsExperimental Treatment1 Intervention
Participants will receive ASP9801 on days 1, 8, 15 and 22 of the first 28 day cycle. Participants will receive ASP9801 on days 1 and 15 on the second 28 day cycle at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met.
Group IV: Dose Expansion (Combination Therapy) - visceral lesionsExperimental Treatment1 Intervention
Participants will receive ASP9801 on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met.
Group V: Dose Expansion (Combination Therapy) - cutaneous or subcutaneous lesionsExperimental Treatment1 Intervention
Participants will receive ASP9801 on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met.
Group VI: Dose Expansion (Combination Induction Therapy) - cutaneous or subcutaneous lesionsExperimental Treatment1 Intervention
Participants will receive ASP9801 on days 1, 8, 15 and 22 of first 28 day cycle at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. Participants will receive ASP9801 on days 1 and 15 on the second 28 day cycle at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met.
Group VII: Dose Escalation - visceral lesionsExperimental Treatment1 Intervention
Participants will receive ASP9801 on days 1 and 15 of 28 day cycles to determine the recommended phase 2 dose. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met.
Group VIII: Dose Escalation - cutaneous or subcutaneous lesionsExperimental Treatment1 Intervention
Participants will receive ASP9801 on days 1 and 15 of 28 day cycles to determine the recommended phase 2 dose. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,955 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,628 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,769 Previous Clinical Trials
8,062,128 Total Patients Enrolled

Media Library

ASP9801 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03954067 — Phase 1
Cancer Research Study Groups: Dose Escalation - cutaneous or subcutaneous lesions, Dose Escalation - visceral lesions, Dose Expansion (Monotherapy) - cutaneous or subcutaneous lesions, Dose Expansion (Monotherapy) - visceral lesions, Dose Expansion (Combination Therapy) - cutaneous or subcutaneous lesions, Dose Expansion (Combination Induction Therapy) - cutaneous or subcutaneous lesions, Dose Expansion (Combination Therapy) - visceral lesions, Dose Expansion (Monotherapy Induction) - cutaneous or subcutaneous lesions
Cancer Clinical Trial 2023: ASP9801 Highlights & Side Effects. Trial Name: NCT03954067 — Phase 1
ASP9801 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03954067 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the observed safety outcomes of utilizing ASP9801?

"Safety of the drug ASP9801 has been evaluated and scored as a 1 due to its Phase 1 status, meaning there is only limited evidence pointing towards its efficacy and safety."

Answered by AI

How many locales are conducting this empirical examination?

"This investigation is enrolling participants in 24 distinct medical centres, such as Fox Chase Cancer Center in Philadelphia, Greenville Health System Cancer Institute in Greenville and The University of Chicago Medical Centre."

Answered by AI

What desired outcomes is this experiment striving to accomplish?

"Per the Astellas Pharma Global Development, Inc., sponsor of this study, the key performance indicator will be safety and tolerability evaluated through patient-reported adverse events over a 12 month period. Secondary metrics to track include objective response rate based on modified RECIST criteria, changes in antitumor activity from baseline readings, and viral shedding of ASP9801 detected by qPCR tests."

Answered by AI

Is enrollment still open for this exploration?

"Affirmative. According to the clinicaltrials.gov entry, recruitment is underway for this experiment which was initially posted on August 8th 2019 and revised November 9th 2022. 260 participants are needed from 24 different sites."

Answered by AI

What is the current size of this research project's participant pool?

"Astellas Pharma Global Development, Inc. will be overseeing the trial from multiple sites including Fox Chase Cancer Center in Philadelphia and Greenville Health System Cancer Institute in South carolina with a total recruitment goal of 260 individuals that meet all eligibility requirements."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
California Cancer Associates for Research & Excellence
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
~1 spots leftby Apr 2024