What side effects are associated with this type of intervention?

Common side effects of oncolytic viruses like ASP9801 include flu-like symptoms, injection site reactions, and immune-related effects. Pembrolizumab, a PD-1 checkpoint inhibitor, often causes fatigue, rash, itching, diarrhea, and more severe immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Both treatments can lead to significant immune-related side effects as they enhance the body's immune response to fight cancer.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 checkpoint inhibitor, has received FDA approval for treating several cancers, including non-small cell lung cancer (NSCLC), melanoma, and esophageal cancer. Other PD-1 inhibitors like nivolumab and avelumab have also been approved for similar indications. While antitumor agents like oncolytic viruses are less commonly approved, they are being actively studied in combination with checkpoint inhibitors to enhance antitumor activity.

What other types of research exist?

Promising alternatives to ASP9801 and Pembrolizumab for cancer treatment in 2024 include: 1) Nivolumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown efficacy in various cancers including melanoma and renal cell carcinoma. 2) Atezolizumab (PD-L1 inhibitor) combined with chemotherapy, which has been effective in non-small cell lung cancer. 3) Relatlimab (LAG-3 inhibitor) combined with Nivolumab, which has shown promise in advanced melanoma. 4) Lenvatinib (multi-kinase inhibitor) combined with Pembrolizumab, which has demonstrated efficacy in renal cell carcinoma and endometrial cancer. These alternatives offer different mechanisms of action and combination strategies that may enhance treatment efficacy.

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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 below

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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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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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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:

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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.

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I have received a transplant from another person.

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I am experiencing significant side effects from cancer treatment.

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I have an active tuberculosis infection.

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I stopped a specific cancer treatment due to side effects.

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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

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

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 more

Secondary 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 more

Awards & 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

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

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

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

0 / 18Eligibility criteria met

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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