Only 17 spots left

~17 spots leftby Dec 2025

AdAPT-001 for Cancer
(BETA-PRIME Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: EpicentRx, Inc.

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Active infection, HIV, Hepatitis, Autoimmune, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have chemotherapy or immunotherapy within 14 days of starting the study treatment. Hormonal therapies and certain other treatments are allowed.

What makes the drug AdAPT-001 unique for cancer treatment?

The research provided does not contain specific information about AdAPT-001, so I cannot determine what makes it unique compared to other cancer treatments.¹ ² ³ ⁴ ⁵

Research Team

Bryan Oronsky, MD PhD

Principal Investigator

EpicentRx, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Subject has an INR < 1.5

I have an advanced cancer that has been confirmed by tests, and it's accessible for treatment.

I am 18 years old or older.

See 14 more

Exclusion 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.

See 6 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Safety Run-In

Participants receive a single injection of AdAPT-001 to determine the highest safe and tolerable dose

28 days

1 visit (in-person)

Dose Expansion Single-Agent

Participants receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles

6 months

12 visits (in-person)

Expansion

Participants receive AdAPT-001 with or without a checkpoint inhibitor on Days 1 and 15 of 28-day cycles

6 months

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

AdAPT-001 (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

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 Clinic Near You

Who Is Running the Clinical Trial?

EpicentRx, Inc.

Lead Sponsor

Trials

Recruited

1,000+

Findings from Research

Research has shown that tumor antigens can trigger immune responses in cancer patients, but these responses often fail to stop tumor progression, highlighting the need for enhanced immunization strategies.

Early clinical trials of cancer vaccines have shown some clinical benefits, but challenges remain in identifying effective antigens, defining the immune responses needed, and selecting suitable delivery systems for the vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer vaccines and immunotherapies: emerging perspectives.Henderson, RA., Mossman, S., Nairn, N., et al.[2005]