Overview
A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors
Status:
Recruiting
Recruiting
Trial end date:
2024-03-01
2024-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
EpicentRx, Inc.Treatments:
Immune Checkpoint Inhibitors
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 and/or palpable
for treatment. Ultrasound guidance may be used to aid administration.
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) ≥ 8.0 g/dL; ≥ 5.6 mmol/L
8. Subject has an INR < 1.5
9. 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.
10. Subject is willing and able to comply with all protocol procedures, evaluations and
rescue measures.
11. OPTIONAL: Archival formalin-fixed paraffin-embedded block(s) or previously cut
archival tissue for at least 5 unstained slides (if available).
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 uncontrolled active bacterial, fungal, or viral infection. No subject with an
active SARS-CoV-2 infection (within 14 days of a positive test)
3. Known positive history of human immunodeficiency virus (HIV) test
4. Subjects who have active hepatitis.
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 in any condition requiring systemic treatment with corticosteroids
(prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive
agents within 14 days before AdAPT-001), but currently or previously treated with any
of the following steroid regimens were included: Topical, ophthalmic, intra-articular,
intranasal, or inhaled corticosteroids with minimal systemic absorption; prophylactic
short-term use of corticosteroids.
7. Prior adenoviral therapy for any indication except vaccination against infectious
disease. Subjects receiving COVID-19 or live vaccination, cannot start treatment until
7 days after completing the vaccination. Recommend waiting at least 28 days from
AdAPT-001 dose prior to receiving COVID-19 vaccination. Concurrent treatment with
Evusheld is allowed.
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.