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ASP9801 + Pembrolizumab for Cancer
Study Summary
This trial is testing a new cancer drug, ASP9801, to see if it is safe and effective. The trial will also study how well the drug works when combined with another cancer drug, pembrolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am currently being treated for another type of cancer.My cancer is confirmed to be advanced or has spread to other parts of my body.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 am fully active or can carry out light work.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 agree not to breastfeed during and for 180 days after the study.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 will not donate eggs during and for 6 months after the study ends.I agree to not have unprotected sex for the duration of the study and 6 months after.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.
- 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
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What have been the observed safety outcomes of utilizing ASP9801?
"Safety of the drug ASP9801 has been evaluated and scored as a 1 due to its Phase 1 status, meaning there is only limited evidence pointing towards its efficacy and safety."
How many locales are conducting this empirical examination?
"This investigation is enrolling participants in 24 distinct medical centres, such as Fox Chase Cancer Center in Philadelphia, Greenville Health System Cancer Institute in Greenville and The University of Chicago Medical Centre."
What desired outcomes is this experiment striving to accomplish?
"Per the Astellas Pharma Global Development, Inc., sponsor of this study, the key performance indicator will be safety and tolerability evaluated through patient-reported adverse events over a 12 month period. Secondary metrics to track include objective response rate based on modified RECIST criteria, changes in antitumor activity from baseline readings, and viral shedding of ASP9801 detected by qPCR tests."
Is enrollment still open for this exploration?
"Affirmative. According to the clinicaltrials.gov entry, recruitment is underway for this experiment which was initially posted on August 8th 2019 and revised November 9th 2022. 260 participants are needed from 24 different sites."
What is the current size of this research project's participant pool?
"Astellas Pharma Global Development, Inc. will be overseeing the trial from multiple sites including Fox Chase Cancer Center in Philadelphia and Greenville Health System Cancer Institute in South carolina with a total recruitment goal of 260 individuals that meet all eligibility requirements."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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