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Virus Therapy
AdAPT-001 for Cancer (BETA-PRIME Trial)
Phase 2
Recruiting
Research Sponsored by EpicentRx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a histologically or cytologically confirmed diagnosis of an advanced malignant solid tumor(s) who have received all conventional therapies considered appropriate by Investigator and have a tumor that is easily accessible and/or palpable for treatment. Ultrasound guidance may be used to aid administration.
Subject's Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening.
Must not have
Chemotherapy or immunotherapy within 14 days of study treatment. Hormonal therapy (including tamoxifen, aromatase inhibitors, and gonadotropin releasing hormone agonists) is allowed. Concurrent treatment with bisphosphonate and RANK ligand inhibitor is allowed.
Subjects with active autoimmune disease or history of autoimmune disease that might recur and may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
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.
Who is the study for?
Adults with advanced solid tumors that have failed conventional treatments can join this trial. They must have good liver, kidney, and blood health, not be pregnant or breastfeeding, use contraception if of childbearing potential, and understand the study's risks. Excluded are those with HIV, active hepatitis or autoimmune diseases requiring steroids, recent chemotherapy or immunotherapy (within 14 days), uncontrolled infections including COVID-19 within 14 days.
What is being tested?
The trial is testing AdAPT-001—an oncolytic virus injected into tumors—to determine its highest safe dose for future cancer treatment. It's a first-in-human study to see if it could help treat various cancers by injecting directly into the tumor sites.
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to viral therapies such as fever, chills, fatigue; injection site pain; immune responses like inflammation; and flu-like symptoms due to the body's reaction to the virus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an advanced cancer that has been confirmed by tests, and it's accessible for treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had chemotherapy or immunotherapy in the last 14 days, but I may be on hormonal therapy or treatments for bone health.
Select...
I do not have an active autoimmune disease or a history that could affect my organs or require steroids.
Select...
I have active hepatitis.
Select...
I do not have any uncontrolled infections and have not tested positive for COVID-19 in the last 14 days.
Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anti-tumor activity of the two-arm dose regimens of AdAPT-001 in Phase 2
Dose Limiting Toxicities (DLT)
Maximum tolerated dose
+1 moreSecondary study objectives
Anti-tumor activity of AdAPT-001
Objective response rate
Other study objectives
Anti-tumor activity by iRECIST
Biodistribution
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2 (Enrollment Open)Experimental Treatment2 Interventions
Approximately 55 to 80 subjects with advanced solid tumors including sarcoma to receive either AdAPT-001 on Days 1 and 15 of 28-day cycles or AdAPT-001 on Days 1 and 15 plus a checkpoint inhibitor of 28-day cycles..
Group II: PART 3: Expansion (Enrollment Completed)Experimental Treatment2 Interventions
Up to 45 subjects will be enrolled in the expansion cohort to receive either AdAPT-001 on Days 1 and 15 of 28-day cycles or AdAPT-001 on Days 1 and 15 plus a checkpoint inhibitor of 28-day cycles.
Group III: PART 2: Dose Expansion Single-Agent (Enrollment Completed)Experimental Treatment1 Intervention
6 subjects will be enrolled in the Lead In Cohort. A Safety Analysis will be performed after 6 subjects have received at least 24 doses. Upon Safety team review as a continuous reassessment of safety, an additional 19 subjects may be enrolled. All subjects in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles.
Group IV: PART 1: Dose Escalation Safety Run-In (Enrollment Completed)Experimental Treatment1 Intervention
Subjects will be treated with AdAPT-001 as a single injection, one time.
Find a Location
Who is running the clinical trial?
EpicentRx, Inc.Lead Sponsor
15 Previous Clinical Trials
892 Total Patients Enrolled
Bryan Oronsky, MD PhDStudy DirectorEpicentRx, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 (Enrollment Open)
- Group 2: PART 3: Expansion (Enrollment Completed)
- Group 3: PART 1: Dose Escalation Safety Run-In (Enrollment Completed)
- Group 4: PART 2: Dose Expansion Single-Agent (Enrollment Completed)
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.
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