What side effects are associated with this type of intervention?

Common side effects of oncolytic virus therapies, such as ASP1012, include flu-like symptoms (fever, chills, fatigue, muscle aches), injection site reactions, and nausea. More severe immune-related adverse events can occur, such as inflammation of organs (colitis, pneumonitis). When combined with immunotherapies, additional side effects may include skin rashes, diarrhea, and endocrine disorders due to the activation of the immune system.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that leverage the immune system to target cancer cells. One notable example is T-VEC (talimogene laherparepvec), an oncolytic virus approved for the treatment of melanoma. T-VEC works similarly to ASP1012 by selectively infecting and killing cancer cells while stimulating an immune response against the tumor. Additionally, immune checkpoint inhibitors such as pembrolizumab and nivolumab have been approved for various solid tumors, enhancing the body's immune response to cancer cells. These treatments represent significant advancements in cancer therapy by utilizing the body's immune system to combat malignancies.

What other types of research exist?

Promising novel alternatives to ASP1012 for solid tumor patients include: 1) Talimogene laherparepvec (T-VEC), an oncolytic virus approved for melanoma that may have potential in other solid tumors. 2) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which have shown efficacy in various solid tumors. 3) Combination therapies like nivolumab plus ipilimumab, which enhance the immune response against cancer cells. 4) Emerging therapies like fecal microbiota transplantation (FMT) that may improve response to immunotherapy in solid tumors.

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Virus Therapy

ASP1012 + Pembrolizumab for Cancer

Phase 1

Recruiting

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

Participants with previously treated cutaneous melanoma, that is, anti-programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) alone or in combination with anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor. Participants with BRAF-mutant melanoma must have received a v-raf murine sarcoma viral oncogene homolog B (BRAF) inhibitor as monotherapy or in combination with other targeted agents (for example, murine embryonic fibroblasts (MEK) inhibitors).

Participants with previously treated solid tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 19 months

Awards & highlights

Summary

This trial tests ASP1012, a modified virus that targets and kills cancer cells, in adults with advanced or spreading tumors. The study aims to find a safe dose and check for side effects. ASP1012 helps the immune system recognize and fight cancer cells.

Who is the study for?

Adults with advanced solid tumors that have grown or spread and who've tried all standard treatments can join. It's not for those with a specific skin cancer (acral lentiginous melanoma) or ovarian cancer patients in remission without measurable disease. Participants must have confirmed diagnoses, and some will need to show certain biomarkers.

What is being tested?

ASP1012, an oncolytic virus designed to target and kill cancer cells while sparing healthy ones, is being tested alone or with pembrolizumab (an approved drug). The trial has three parts: dose finding, expanding the dose to more patients, and testing in specific cancers like stomach and colorectal.

What are the potential side effects?

Potential side effects are not listed but may include typical reactions from immune therapies such as flu-like symptoms, fatigue, allergic reactions, or issues at the infusion site since ASP1012 is given via vein.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had melanoma treatment with specific immunotherapies or targeted therapies if my melanoma has a BRAF mutation.

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I have had treatment for a solid tumor before.

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I do not have acral lentiginous melanoma.

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My cancer is advanced or has spread, confirmed by a lab test.

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My melanoma is at an advanced stage but can still be surgically removed and I haven't received any treatment yet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 19 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 19 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 19 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

Incidence of Dose Limiting Toxicities (DLTs)

Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores

Number of participants with Adverse Events (AEs)

+3 more

Secondary study objectives

ASP1012 viral DNA in blood

Amount of viral DNA in tumor tissues

Change from baseline in cancer antigen 125 (CA-125) (Ovarian cancer only)

+14 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part 3: ASP1012 Dose Expansion (previously treated gastric cancer)Experimental Treatment1 Intervention

Participants with previously treated gastric cancer will receive ASP1012 with dose level selected from dose escalation (Part 1) in a 21-day cycle.

Group II: Part 3: ASP1012 Dose Expansion (ovarian cancer)Experimental Treatment1 Intervention

Participants with ovarian cancer will receive ASP1012 with dose level selected from dose escalation (Part 1) in a 21-day cycle.

Group III: Part 3: ASP1012 Dose Expansion (other solid tumor type)Experimental Treatment1 Intervention

Participants with other solid tumor type will receive ASP1012 with dose level selected from dose escalation (Part 1) in a 21-day cycle.

Group IV: Part 3: ASP1012 Dose Expansion (colorectal cancer [CRC])Experimental Treatment1 Intervention

Participants with CRC will receive ASP1012 with dose level selected from dose escalation (Part 1) in a 21-day cycle.

Group V: Part 2: ASP1012 Dose Expansion (Monotherapy)Experimental Treatment1 Intervention

Participants with previously treated melanoma will receive ASP1012 with dose level(s) selected from dose escalation (Part 1) in a 21-day cycle.

Group VI: Part 2: ASP1012 + Pembrolizumab Dose Expansion (treatment-naïve melanoma)Experimental Treatment2 Interventions

Participants with treatment-naïve melanoma will receive ASP1012 in a 21-day cycle. Pembrolizumab will also be administered every three weeks in a 21-day cycle, for up to 3 doses.

Group VII: Part 2: ASP1012 + Pembrolizumab Dose Expansion (previously treated solid tumors)Experimental Treatment2 Interventions

Participants with previously treated solid tumors, will receive ASP1012 in a 21-day cycle. Pembrolizumab will also be administered every three weeks in a 21-day cycle, for up to 3 doses.

Group VIII: Part 1: ASP1012 Dose EscalationExperimental Treatment1 Intervention

Participants with previously treated solid tumor types will receive ASP1012 in a 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2070

0 / 5Eligibility 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

Oncolytic viruses like ASP1012 are designed to selectively infect and kill cancer cells while sparing healthy cells. They also make cancer cells more visible to the immune system, prompting an immune response against the tumor. This dual mechanism is particularly important for solid tumor patients as it directly targets the tumor and boosts the body's natural defenses. Other common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells, and immunotherapy, which enhances the immune system's ability to fight cancer. These treatments aim to reduce tumor size, control disease progression, and improve patient outcomes.

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Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor

199 Previous Clinical Trials

122,448 Total Patients Enrolled

Central ContactStudy DirectorAstellas Pharma Global Development, Inc.

99 Previous Clinical Trials

6,397,258 Total Patients Enrolled

~153 spots leftby Jun 2029

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