ASP1012 + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, it mentions that participants must comply with prohibited medication restrictions, so it's best to discuss your specific medications with the study team.
Is the combination of ASP1012 and Pembrolizumab safe for humans?
Pembrolizumab, also known as KEYTRUDA or MK-3475, has been studied for safety in various cancers. It generally has a favorable safety profile, but there are rare serious side effects, including infections, heart issues, and lung inflammation. The risk of fatal adverse events is similar to chemotherapy, and it varies depending on the type of cancer and whether it is combined with other treatments.12345
What makes the drug ASP1012 + Pembrolizumab unique for cancer treatment?
The combination of ASP1012 with Pembrolizumab is unique because it aims to enhance the immune system's ability to fight cancer by combining Pembrolizumab, a well-established immune checkpoint inhibitor, with ASP1012, which may have a novel mechanism or target. This combination could potentially improve outcomes in cancers that are less responsive to Pembrolizumab alone.46789
What data supports the effectiveness of the drug pembrolizumab in cancer treatment?
Research shows that pembrolizumab, a drug that helps the immune system fight cancer, improves survival in patients with advanced lung cancer and melanoma. It has been effective in patients with specific markers on their cancer cells, leading to longer life and better quality of life compared to traditional chemotherapy.110111213
Who Is on the Research Team?
Central Contact
Principal Investigator
Astellas Pharma Global Development, Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants with locally advanced or metastatic tumors receive escalating doses of ASP1012 to determine suitable doses for further study parts.
Dose Expansion
Participants receive ASP1012 at doses determined from Dose Escalation phase, with or without pembrolizumab, depending on cancer type.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with clinic visits and phone follow-ups.
What Are the Treatments Tested in This Trial?
Interventions
- ASP1012
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available