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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 has measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.
Must not have
Subject with inadequate organ and marrow functions meeting any of the below criteria: Leukocytes < 3000/μL, Absolute neutrophil count < 1500/μL, Platelets < 100,000/μL, Hemoglobin (Hgb) < 9 g/dL (Criteria must be met without packed red blood cell transfusion within the prior 2 weeks. Subjects can be on stable dose of erythropoietin [≥ approximately 3 months]), INR > 1.5 × ULN and/or aPTT > 1.5 × institutional normal limits, except for subjects in Group B (Visceral Lesions) escalation and expansion groups where INR and aPTT must be normal, TBL > 1.5 × institutional normal limits (subjects with known Gilbert syndrome who are excluded if TBL > 3.0 × institutional normal limits or direct bilirubin > 1.5 × institutional normal limits), AST and ALT > 2.5 × institutional normal limits. Subjects with tumors in the liver AST and ALT > 5 × institutional normal limits., Albumin < 3.0 g/dL, Creatinine > 1.5 × institutional normal limits.
Subject with another malignancy that currently requires treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, ASP9801, alone and with Pembrolizumab, in patients with skin and internal organ tumors. It aims to find safe and effective treatments for those who may not respond to standard therapies. Pembrolizumab has shown effectiveness in various cancers, including lung, head and neck, endometrial, and liver cancer.
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.
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.
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 belowSelect...
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.
Select...
My condition worsened after treatment, or I can't tolerate/have refused all known beneficial therapies.
Select...
I have a tumor that can be measured and is the right size for a direct injection.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for another type of cancer.
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I have had or currently have lung inflammation treated with steroids.
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I have had a severe allergic reaction to pembrolizumab or its ingredients.
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I had major surgery more than 4 weeks ago and have recovered.
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I am currently being treated for an infection.
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I have not received a live vaccine in the last 30 days.
Select...
I have received a transplant from another person.
Select...
I am experiencing significant side effects from cancer treatment.
Select...
I have an active tuberculosis infection.
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I stopped a specific cancer treatment due to side effects.
Select...
I have previously been treated with ASP9801.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~2810
ASP9801
2019
Completed Phase 1
~80
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Antitumor agents, such as ASP9801, work by directly targeting and destroying cancer cells, often through mechanisms like inducing cell death or inhibiting cell division. PD-1 checkpoint inhibitors, like pembrolizumab, enhance the immune system's ability to recognize and attack cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection.
These treatments are crucial for cancer patients as they offer targeted approaches to combat cancer, potentially leading to better outcomes and fewer side effects compared to traditional therapies.
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Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
122,282 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,985 Previous Clinical Trials
5,178,629 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,868 Previous Clinical Trials
8,082,558 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for another type of cancer.My cancer is confirmed to be advanced or has spread to other parts.I am a man who will use birth control during and for 6 months after treatment.I agree not to breastfeed during and for 180 days after the study ends.I will not donate sperm during and for 6 months after the study treatment.My condition worsened after treatment, or I can't tolerate/have refused all known beneficial therapies.I have had or currently have lung inflammation treated with steroids.I am not pregnant and agree to follow contraceptive guidelines if of childbearing potential.I can understand and am willing to sign the consent form.I have had a severe allergic reaction to pembrolizumab or its ingredients.I had major surgery more than 4 weeks ago and have recovered.I do not have active brain metastases or untreated brain cancer spread.I am currently being treated for an infection.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am not in another study and haven't taken any experimental drugs recently.I have a tumor that can be measured and is the right size for a direct injection.My tumor is near major blood vessels or vital nerves, making it risky for direct injections, but I have other tumors that can be injected.I haven't needed systemic therapy for autoimmune or inflammatory disorders in the last 2 years.I have a tumor that can be measured and is the right size for a specific injection.I've had serious liver-related symptoms like fluid buildup or bleeding in my stomach in the last 6 months.I have had serious heart issues in the last year but got clearance from a cardiologist.I have not received a live vaccine in the last 30 days.I agree to use contraception or remain abstinent for 6 months after the last study treatment.I have health issues that make certain treatments risky for me.I have received a transplant from another person.I will not donate eggs during and for 6 months after the study ends.You are not able to become pregnant OR if you are able to become pregnant, you agree to use birth control during the study and for 6 months after the study ends.I am experiencing significant side effects from cancer treatment.I have an active tuberculosis infection.You are allergic to ASP9801 or any of its ingredients, or have had a negative reaction to the smallpox vaccine.I am willing and able to follow the study rules and avoid certain medications.I stopped a specific cancer treatment due to side effects.I am willing to have at least 2 tumor biopsies as per my hospital's rules.I have previously been treated with ASP9801.I had radiation therapy over 2 weeks ago, have no side effects, and didn't need steroids.You are expected to live for at least 12 more weeks.I am fully active or can carry out light work.My condition worsened after treatment, or I couldn't tolerate or refused all known beneficial therapies.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation - cutaneous or subcutaneous lesions
- Group 2: Dose Escalation - visceral lesions
- Group 3: Dose Expansion (Monotherapy) - cutaneous or subcutaneous lesions
- Group 4: Dose Expansion (Monotherapy) - visceral lesions
- Group 5: Dose Expansion (Combination Therapy) - cutaneous or subcutaneous lesions
- Group 6: Dose Expansion (Combination Induction Therapy) - cutaneous or subcutaneous lesions
- Group 7: Dose Expansion (Combination Therapy) - visceral lesions
- Group 8: Dose Expansion (Monotherapy Induction) - cutaneous or subcutaneous lesions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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