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AdAPT-001 for Cancer (BETA-PRIME Trial)
BETA-PRIME Trial Summary
This trial is testing a new cancer treatment, AdAPT-001, which is an injected virus that kills cancer cells. The purpose is to find the highest dose that is safe and tolerable. If successful, this could be used to treat others with cancer in the future.
BETA-PRIME Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBETA-PRIME Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BETA-PRIME Trial Design
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Who is running the clinical trial?
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- You have a serious medical condition or an untreated health problem that could interfere with the study.I have not had adenoviral therapy except for vaccines, and it's been 7 days since my last vaccine.I haven't had chemotherapy or immunotherapy in the last 14 days, but I may be on hormonal therapy or treatments for bone health.I do not have an active autoimmune disease or a history that could affect my organs or require steroids.I have an advanced cancer that has been confirmed by tests, and it's accessible for treatment.I am 18 years old or older.I am willing and able to follow all study requirements.I can take care of myself and am up and about more than half of my waking hours.I can provide tissue samples if needed.I agree to use effective birth control during and after the study.My liver is functioning well, according to recent tests.I haven't taken strong steroids or immunosuppressants in the last 14 days, except for minor uses like creams or inhalers.I have active hepatitis.I do not have any uncontrolled infections and have not tested positive for COVID-19 in the last 14 days.I understand the study's risks and have signed the consent form.I am not pregnant or breastfeeding.
- Group 1: Phase 2
- Group 2: PART 1: Dose Escalation Safety Run-In (Enrollment Completed)
- Group 3: PART 2: Dose Expansion Single-Agent (Enrollment Completed)
- Group 4: PART 3: Expansion
- 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
How many participants are involved in this medical research?
"Affirmative, the data hosted on clinicaltrials.gov attests that this medical trial is actively recruiting participants. The investigation was first posted back in March 29th 2021 and has been revised as recently as August 31st 2022. 40 individuals are needed for 6 different sites to take part in this study."
How many medical centers are taking part in the experiment?
"Six medical centres are involved in the running of this trial, including Mary Crowley Cancer Research (Dallas), Cleveland Clinic (Cleveland) and MD Anderson Cancer Center (Houston). There are also three additional facilities."
Has the AdAPT-001 drug been sanctioned by the FDA?
"Due to limited data regarding its safety and efficacy, AdAPT-001 was assigned a score of 1 on the risk scale."
Are there any open slots in this clinical trial at the present time?
"Affirmative. Clinicaltrials.gov contains evidence that this medical trial, initially announced on March 29th 2021, is actively recruiting patients. In total, 40 individuals are required to be recruited from 6 different locations."
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