Clinical Trials /

A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors

NCT04673942

Description:

This is the first clinical trial of AdAPT-001 for the treatment of cancer. AdAPT-001 is an oncolytic virus that is injected directly into the tumor. The purpose of this study is to find out the highest dose of AdAPT-001 that is safe and tolerable. This is the first step in studying whether it can be used to treat others with cancer in the future.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors
  • Official Title: A Phase I, First in Human, Study to Evaluate the Safety and Tolerability of AdAPT-001 in Subjects With Refractory Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: BETA-PRIME
  • NCT ID: NCT04673942

Conditions

  • Solid Tumor, Adult
  • Cancer
  • Neoplasms

Interventions

DrugSynonymsArms
AdAPT-001Part 1: Dose Escalation Safety Run-In

Purpose

This is the first clinical trial of AdAPT-001 for the treatment of cancer. AdAPT-001 is an oncolytic virus that is injected directly into the tumor. The purpose of this study is to find out the highest dose of AdAPT-001 that is safe and tolerable. This is the first step in studying whether it can be used to treat others with cancer in the future.

Detailed Description

      This is a dose escalation protocol to determine, first and foremost, the safety, tolerability
      and feasibility of intratumoral administration of AdAPT-001.

      The study has 2 parts. Different groups of patients will participate in each part.

      PART 1: Dose Escalation Safety Run-In

      During part 1, all participants will be treated with AdAPT-001 as a single injection, one
      time. Participants will be assigned to different dose levels to find the highest dose of
      AdAPT-001 that is safe and tolerable.

      PART 2: Dose Expansion Single-Agent

      All participants in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day
      cycles. The dose of AdAPT-001 used in Part 2 will be decided by the results from Part 1.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose Escalation Safety Run-InExperimentalSubjects will be treated with AdAPT-001 as a single injection, one time.
  • AdAPT-001
Part 2: Dose Expansion Single-AgentExperimental6 subjects will be enrolled in the Lead In Cohort. A Safety Analysis will be performed after 6 subjects have received at least 4 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.
  • AdAPT-001

Eligibility Criteria

        Inclusion Criteria:

          1. Subject is capable of understanding the purpose and risks of the study and has
             provided written Informed Consent.

          2. Subject is male or female, aged at least 18 years.

          3. 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 for treatment.

          4. Subject's Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening.

          5. Subject has acceptable liver function at Screening, as evidenced by:

               1. Bilirubin < 1.5 x ULN (upper limit of normal)

               2. AST (SGOT) and ALT (SGPT) < 3.0 x ULN (upper limit of normal)

               3. Alkaline Phosphatase < 2.5 x ULN (upper limit of normal)

          6. Subject has a Serum Creatinine < 1.5 x ULN (upper limit of normal)

          7. Subject has acceptable hematologic status at Screening, as evidenced by:

               1. Absolute neutrophil count > 1,500 cells/mm3; > 1.5 x 109/L, and

               2. Platelet count > 75,000/mm3; > 75.0 x 109/L, and

               3. Hemoglobin (HGB) > 10.0 g/dL; > 6.2 mmol/L

          8. Subject has an INR < 1.5

          9. Archival formalin-fixed paraffin-embedded block(s) or previously cut archival tissue
             for at least 5 unstained slides (if available).

         10. Female subjects of childbearing potential (i.e., women who have not been surgically
             sterilized or have not been post-menopausal for at least one year), and male subjects
             with partners of childbearing potential, must agree to use medically acceptable
             methods of contraception beginning on Study Day 1 and continuing until at least four
             weeks after administration of the subject's final dose of AdAPT-001. Medically
             acceptable contraception is defined as either: 1) usage by at least one of the
             partners of a barrier method of contraception, together with usage by the female
             partner, commencing at least three months prior to Study Day 1, of a stable regimen of
             any form of hormonal contraception or an intra-uterine device, or 2) usage by the
             couple of a double-barrier method of contraception. Use of a single-barrier method
             alone or abstinence alone is not considered adequate.

         11. Subject is willing and able to comply with all protocol procedures, evaluations and
             rescue measures.

        Exclusion Criteria:

          1. Presence of a serious co-morbid medical condition, or a clinically significant
             laboratory finding(s) that, in the opinion of the Investigator, suggests the presence
             of an infectious, endocrine, and/or other inadequately treated systemic disorder.

          2. A known active bacterial, fungal, or viral infection.

          3. Known positive human immunodeficiency virus (HIV)

          4. Known history of hepatitis B or C. Patients with a known history of hepatitis B or C
             will be eligible only if they have an undetectable viral load during screening.

          5. If female, subject is pregnant and/or breastfeeding.

          6. 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. NOTE: Subjects having a
             condition requiring systemic treatment with either corticosteroids (> 10 mg daily
             prednisone equivalents) or other immunosuppressive medications within 14 days of study
             agent administration. Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) is
             allowed.

          7. Prior adenoviral therapy for any indication except vaccination against infectious
             disease.

          8. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicities (DLT)
Time Frame:28 days
Safety Issue:
Description:All subjects in part 1 will be assessed for the development of dose-limiting toxicity (DLT) during treatment with AdAPT-001. The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

Secondary Outcome Measures

Measure:Anti-tumor activity of AdAPT-001
Time Frame:6 months
Safety Issue:
Description:In part 2, overall response rate (ORR) and best overall response rates per response evaluation criteria outlined in Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), as well as progression-free survival (PFS), and duration of response will be assessed.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:EpicentRx, Inc.

Trial Keywords

  • oncolytic virus
  • immunotherapy
  • adenovirus
  • intratumoral injection
  • AdAPT-001

Last Updated

January 27, 2021