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Cancer Vaccine
ASP7517 + Pembrolizumab for Advanced Cancer
Phase 1 & 2
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
Participant must be diagnosed with solid tumor known to express WT1 antigen such as, but not limited to melanoma, ovarian cancer or Colorectal Cancer (CRC).
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe, how well it works, and what the best dose is.
Who is the study for?
This trial is for adults with advanced solid tumors known to express WT1 antigen, like melanoma, ovarian cancer, or colorectal cancer. Participants must have an ECOG Performance Status of ≤ 2 and agree to follow contraceptive guidance. They should not be pregnant or breastfeeding and must have received all standard therapies unless unsuitable.Check my eligibility
What is being tested?
The study tests ASP7517 alone and combined with Pembrolizumab in patients with specific cancers expressing the WT1 antigen. It aims to find safe dosages and observe anti-cancer effects by comparing responses when used as a single agent versus in combination.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, fatigue, possible digestive issues, blood disorders that could affect clotting or immunity, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer, like melanoma or ovarian, is known to show WT1 antigen.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer, like melanoma or ovarian, tests positive for WT1.
Select...
I have ovarian cancer with specific genetic features and received certain immune therapies.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have metastatic melanoma and haven't received CPI but have had PD-1 or PD-L1 inhibitors.
Select...
My colorectal cancer has spread, is MSI-H or MMR deficient, and I've had PD-1 or PD-L1 inhibitors before.
Select...
I agree not to breastfeed during and for 180 days after the last treatment.
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My cancer is advanced and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
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 the Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
+6 moreSecondary outcome measures
Disease Control Rate (DCR) per RECIST v1.1
Disease Control Rate per iRECIST (iDCR)
Duration of Overall Survival (OS)
+9 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2 ASP7517 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive RP2D of ASP7517 on Day 1 of each 28-day cycle for up to 6 doses
Group II: Phase 2 ASP7517 + Pembrolizumab Dose ExpansionExperimental Treatment2 Interventions
Participants will receive RP2D of ASP7517 on Day 1 of each 28-day cycle for up to 6 doses in combination with up to 4 doses of pembrolizumab administered every 6 weeks. Pembrolizumab monotherapy may be extended up to a total of 17 doses for qualifying participants.
Group III: Phase 1 ASP7517 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants will receive ASP7517 on Day 1 of each 28-day cycle for up to 6 doses.
Group IV: Phase 1 ASP7517 + Pembrolizumab Dose EscalationExperimental Treatment2 Interventions
Participants will receive ASP7517 on Day 1 of each 28-day cycle for up to 6 doses in combination with up to 4 doses of pembrolizumab administered every 6 weeks starting from Cycle 1 Day 1. Pembrolizumab monotherapy may be extended up to a total of 17 doses for qualifying participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASP7517
2019
Completed Phase 2
~50
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
194 Previous Clinical Trials
121,352 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,782 Previous Clinical Trials
8,066,292 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 45 kg.I have not received a live vaccine in the last 28 days.I have had lung inflammation caused by drugs, radiation, or other non-infectious factors.I have had a bone marrow or organ transplant from another person.My organs are functioning well and I haven't had a blood transfusion in the last 4 weeks.My side effects from previous treatments, except for hair loss, have mostly gone away.My cancer, like melanoma or ovarian, is known to show WT1 antigen.I have not taken steroids or immunosuppressants in the last 14 days.My cancer is advanced and cannot be removed by surgery, and I've tried all standard treatments.I haven't taken any experimental drugs within the last 21 days or 5 half-lives before starting the trial drug.I stopped my cancer treatment 21 days or 5 half-lives ago, except for specific lung cancer drugs.My tumor type has responded to specific treatments or is suitable for ASP7517 therapy.I have metastatic melanoma and haven't been treated with CPIs.I can take care of myself and am up and about more than half of my waking hours.My cancer, like melanoma or ovarian, tests positive for WT1.I have not had any cancer except for treatable local cancer in the past 2 years.I am a male using contraception, not donating sperm, and if sexually active with a pregnant partner, using a condom.I have had heart problems in the last year without seeing a cardiologist.I have ovarian cancer with specific genetic features and received certain immune therapies.I can take care of myself but might not be able to do heavy physical work.My organs are functioning well enough for treatment.I am not pregnant, not capable of becoming pregnant, not breastfeeding, and not donating eggs.I finished my radiotherapy at least 2 weeks ago.It's been over 3 weeks since my last cancer treatment.I have metastatic melanoma and haven't received CPI but have had PD-1 or PD-L1 inhibitors.I haven't had a heart attack or unstable chest pain in the last 6 months.My colorectal cancer has spread, is MSI-H or MMR deficient, and I've had PD-1 or PD-L1 inhibitors before.You have an ongoing autoimmune disease that is currently active.My side effects from previous treatments have mostly gone away or returned to normal in the last 2 weeks.I agree not to breastfeed during and for 180 days after the last treatment.I will need additional cancer treatment while on this trial.My cancer is advanced and cannot be removed by surgery.You are not able to become pregnant or you agree to use birth control during the study and for 6 months after it is completed.I agree to provide a sample of my tumor for the study.I have been diagnosed with HIV.I have tried all standard treatments for my cancer, unless they were not suitable or caused too many side effects.I stopped my previous immune therapy because of severe side effects.I have not had major surgery in the last 28 days.I have not taken medication for an infection in the last 14 days.I have brain metastases that are causing symptoms or are unstable.You are not eligible to participate in the study.I finished any form of radiotherapy at least 2 weeks ago.I agree to have a tumor biopsy if it's possible and safe.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 ASP7517 Monotherapy Dose Expansion
- Group 2: Phase 2 ASP7517 + Pembrolizumab Dose Expansion
- Group 3: Phase 1 ASP7517 Monotherapy Dose Escalation
- Group 4: Phase 1 ASP7517 + Pembrolizumab Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the number of healthcare facilities administering this experiment?
"Participants for this medical study can be found at Emory University, located in Atlanta; U of Iowa Hospitals situated in Iowa City; and the University of Chicago based in Illinois. Additionally, there are 4 more trial sites where recruitment is taking place."
Answered by AI
Are there other precedents for the use of ASP7517 in clinical research?
"The initial research involving ASP7517 occurred at City of Hope in 2010, with follow-up studies totaling 251. Currently 961 active clinical trials are underway, predominantly located within Atlanta, Georgia."
Answered by AI
What medical afflictions is ASP7517 commonly prescribed to address?
"ASP7517 can be used to treat a variety of malignant neoplasms, including unresectable melanoma, microsatellite instability high diseases and those with progression after chemotherapy."
Answered by AI
How many individuals have enrolled as participants in this research?
"To properly execute this trial, 385 qualified subjects are necessary. Astellas Pharma Global Development, Inc., is responsible for the study's management and will oversee its progress from several different medical facilities; two of which are Emory University in Atlanta and University of Iowa Hospitals in Iowa City."
Answered by AI
Are any new participants accepted into this experiment?
"According to clinicaltrials.gov, this experimental drug trial is in the process of recruiting participants. It was initially announced on December 6th 2021 and has been most recently updated on November 23rd 2022."
Answered by AI
What objectives is this experiment hoping to accomplish?
"This 24-month clinical trial will assess Dose Limiting Toxicities (DLTs) as its primary outcome. Secondary objectives include Progression Free Survival per iRECIST and RECIST v1.1, both evaluated independently by central review or investigator assessment respectively."
Answered by AI
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