An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors
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.
• 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 and/or palpable for treatment. Ultrasound guidance may be used to aid administration.
• Subject's Eastern Cooperative Group (ECOG) performance status is 0-1 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) ≥ 8.0 g/dL; ≥ 5.6 mmol/L
• Subject has an INR \< 1.5
• 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.
⁃ OPTIONAL: Archival formalin-fixed paraffin-embedded block(s) or previously cut archival tissue for at least 5 unstained slides (if available).