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Virus Therapy

Part 2: ASP1012 + Pembrolizumab Dose Expansion (previously treated solid tumors) for Solid Tumors

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

Study Summary

This trial is testing a virus called ASP1012 as a potential treatment for certain cancers. ASP1012 has been modified in a lab to specifically target and kill cancer cells while leaving healthy cells unhar

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.Check my eligibility

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.See study design

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.

Select...

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

ASP1012 viral DNA in blood

Amount of viral DNA in tumor tissues

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

+15 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

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor

192 Previous Clinical Trials

120,857 Total Patients Enrolled

Central ContactStudy DirectorAstellas Pharma Global Development, Inc.

98 Previous Clinical Trials

6,397,133 Total Patients Enrolled

Frequently Asked Questions

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

Are new patients currently being actively recruited for this clinical trial?

"Indeed, the details available on clinicaltrials.gov indicate that this particular study is actively seeking eligible participants. The trial was initially posted on December 12th, 2023 and most recently updated on January 2nd, 2024. To complete the trial successfully, a total of 229 patients will be recruited from one site."

Answered by AI

To what extent does Part 2: ASP1012 Dose Expansion (Monotherapy) pose risks to individuals receiving treatment?

"Given that this trial is in Phase 1, meaning there is limited data supporting both safety and efficacy, our team at Power rates the safety of Part 2: ASP1012 Dose Expansion (Monotherapy) as a 1 on a scale from 1 to 3."

Answered by AI

What is the total number of subjects being examined in this particular research investigation?

"Indeed, the details on clinicaltrials.gov confirm that this investigation is presently enrolling participants. The trial was originally published on December 12th, 2023 and underwent its latest revision on January 2nd, 2024. The study aims to recruit a total of 229 patients from one designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of ASP1012 in Adults With Solid Tumors

2024. "A Study of ASP1012 in Adults With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171178.

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