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