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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

No Placebo-Only Group

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 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 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:

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I haven't had chemotherapy or immunotherapy in the last 14 days, but I may be on hormonal therapy or treatments for bone health.

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I do not have an active autoimmune disease or a history that could affect my organs or require steroids.

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I have active hepatitis.

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I do not have any uncontrolled infections and have not tested positive for COVID-19 in the last 14 days.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 more

Secondary study objectives

Anti-tumor activity of AdAPT-001

Objective response rate

Other study objectives

Anti-tumor activity by iRECIST

Biodistribution

Side effects data

From 2023 Phase 1 & 2 trial • 40 Patients • NCT04020185

71%

Injection site pain

43%

Nausea

43%

Fatigue

29%

Pain

29%

Constipation

14%

Cancer pain

14%

Oral candidiasis

14%

Disease progression

14%

Acute respiratory failure

14%

Injection site erythema

14%

Chills

14%

Injection site irritation

14%

Diarrhoea

14%

Abdominal pain

14%

Peripheral swelling

14%

Vomiting

14%

Abdominal pain upper

14%

Dyspnoea

14%

Cough

14%

Decreased appetite

14%

Hyponatraemia

14%

Hypokalaemia

14%

Headache

14%

Dry mouth

14%

Paraesthesia

14%

Myalgia

14%

Haematuria

14%

Weight decreased

14%

Tremor

14%

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Monotherapy 1200

Combination Therapy 800 μg

Monotherapy 200 μg

Monotherapy 100 μg

Monotherapy 400 μg

Monotherapy 800

Combination Therapy 1200 μg

Combination Therapy 24000 μg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met