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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 is male or female, aged at least 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

BETA-PRIME Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an advanced cancer that has been confirmed by tests, and it's accessible for treatment.
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I am 18 years old or older.
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My liver is functioning well, according to recent tests.
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I am willing and able to follow all study requirements.
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I can take care of myself and am up and about more than half of my waking hours.
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I can provide tissue samples if needed.
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I agree to use effective birth control during and after the study.
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I understand the study's risks and have signed the consent form.

BETA-PRIME Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-tumor activity of the two-arm dose regimens of AdAPT-001 in Phase 2
Dose Limiting Toxicities (DLT)
Maximum tolerated dose
+1 more
Secondary outcome measures
Anti-tumor activity of AdAPT-001
Objective response rate
Other outcome measures
Anti-tumor activity by iRECIST
Biodistribution

BETA-PRIME Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2Experimental 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: ExpansionExperimental 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
914 Total Patients Enrolled
Bryan Oronsky, MD PhDStudy DirectorEpicentRx, Inc.

Media Library

AdAPT-001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04673942 — Phase 2
Sarcoma Research Study Groups: Phase 2, PART 1: Dose Escalation Safety Run-In (Enrollment Completed), PART 2: Dose Expansion Single-Agent (Enrollment Completed), PART 3: Expansion
Sarcoma Clinical Trial 2023: AdAPT-001 Highlights & Side Effects. Trial Name: NCT04673942 — Phase 2
AdAPT-001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04673942 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~50 spots leftby Dec 2025