MC# 21-04 - BETA-PRIME: A Phase I/II, First in Human, Study to Evaluate the Safety and Tolerability of AdAPT-001 in Subjects with Refractory Solid Tumors
Disease Type(s): Solid Tumor
Phase(s): I, II
Drug Classification(s): Viral Therapy
Molecular Target(s): n/a
Mechanism of Action
AdAPT-001 is an oncolytic adenovirus that expresses a TGF-β (beta) trap fusion.
In this study, the sponsor and investigators want to learn:
- How much of AdAPT-001 can be given with an acceptable level of side effects
- The effects of AdAPT-001 (good and bad)
- About the safety and tolerability of AdAPT-001
- If research tests can be used in the future to predict who will benefit from AdAPT-001
- Subject is capable of understanding the purpose and risks of the study and has provided written Informed Consent
- Subject is male or female, aged at least 18 years
- 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
- Subject’s Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening
- Subject has acceptable liver function at Screening, as evidenced by:
- Bilirubin < 1.5 x ULN (upper limit of normal)
- AST (SGOT) and ALT (SGPT) < 3.0 x ULN (upper limit of normal)
- Alkaline Phosphatase < 2.5 x ULN (upper limit of normal)
- Subject has a Serum Creatinine < 1.5 x ULN (upper limit of normal)
- Subject has acceptable hematologic status at Screening, as evidenced by:
- Absolute neutrophil count > 1,500 cells/mm3; > 1.5 x 109/L, and
- Platelet count > 75,000/mm3; > 75.0 x 109/L, and
- Hemoglobin (HGB) > 10.0 g/dL; > 6.2 mmol/L
- Subject an INR < 1.5
- If subject has archival tissue formalin- fixed paraffin-embedded block(s) or previously cut archival tissue, submit 1 H&E slide and 5 unstained slides
- 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.
- Subject is willing and able to comply with all protocol procedures, evaluations and rescue measures
- 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
- A known active bacterial, fungal, or viral infection. No subjects with an active SARS-CoV-2 infection (within 21 days of a positive test)
- Known positive human immunodeficiency virus (HIV)
- 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 at screening
- If female, subject is pregnant and/or breastfeeding
- 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.
- Prior adenoviral therapy for any indication except vaccination against infectious disease. Subjects who receive a COVID-19 vaccination, cannot start treatment until 14 days after completing the vaccination series. It is recommended that subjects wait at least 28 days from AdAPT-001 dose prior to receiving COVID-19 vaccination (end of 28 Day Follow Up visit in Part 1).
- 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.
- Dallas, TX - Mary Crowley Cancer Research - Medical City