IRB Study Number 22-001
Status Recruiting
Phase Phase 1
Institute Taussig Cancer Institute
Description
3.1 PART 1
3.1.1 Primary Objectives
- To determine the safety and tolerability profile of a single dose of AdAPT-001 in subjects with advanced solid tumors that have progressed after treatment with standard therapies or for which there are no appropriate therapies available.
- To identify the maximum tolerated dose (MTD) and/or recommended dose (RD) for a regimen of AdAPT-001 administered intratumorally in subjects with easily injectable advanced solid tumors.
3.2 PART 2
3.2.1 Primary Objectives
- To determine the safety and tolerability profile of a multiple dose regimen of AdAPT-001 in subjects with advanced solid tumors that have progressed after treatment with standard therapies or for which there are no appropriate therapies available.
3.2.2 Secondary Objectives
- Preliminarily to assess anti-tumor activity of AdAPT-001 by objective response rates (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.
3.2.3 Exploratory Objectives
- Preliminarily to assess anti-tumor activity of AdAPT-001 by ORR and best overall response rates per Immune Response Evaluation Criteria in Solid Tumors as outlined in (iRECIST).
- To measure TGFβ trap concentrations in the serum and, in patients who consent to tissue collections, to test for TGFβ trap expression in the treated tumors.
Reference: noveltc
Inclusion Criteria
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 0-2 at Screening.
Subject has acceptable liver function at Screening, as evidenced by:
a. Bilirubin < 1.5 x ULN (upper limit of normal)
b. AST (SGOT) and ALT (SGPT) < 3.0 x ULN (upper limit of normal)
c. 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:
a. Absolute neutrophil count > 1,500 cells/mm3; > 1.5 x 109/L, and
b. Platelet count > 75,000/mm3; > 75.0 x 109/L, and
c. Hemoglobin (HGB) > 8.0 g/dL; > 5.6 mmol/L
Subject 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).
Exclusion Criteria
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 uncontrolled active bacterial, fungal, or viral infection. No subject with an active SARS-CoV-2 infection (within 14 days of a positive test).
Known positive history of human immunodeficiency virus (HIV) test.
Subjects who have active hepatitis.
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 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 corticosteriods with minimal systemic absorption; prophylactic short-term use of corticosteroids.
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.
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.
