Principal Investigator:
Study Sponsor: Astellas Pharma Global Development, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase I
Purpose of study: This is a first-in-human study that is looking to study the safety, and tolerability to determine the maximum tolerated dose of study drug ASP1002. The study is open to multiple tumor types – NSCLC, US, CRC, prostate adenocarcinoma, ovarian, and triple negative breast cancer. It is made up of two parts – Part 1: Dose escalation, where the study will determine the highest dose tolerable, and Part 2: dose expansion, where the determined dose will be tested in the tumor types that had the best response to the study drug.
Inclusion Criteria
– Be 18 years or older at study start.
– Must have locally advanced or metastatic solid tumor as determined by pathology records or biopsy.
For dose escalation, patient must have one of the following tumor types: non small-cell lung cancer, urothelial carcinoma, colorectal cancer, prostate adenocarcinoma, epithelial ovarian cancer, or triple negative breast cancer.
For dose expansion, patient must have: NSCLC, UC, CRC, or any tumor type which had confirmed response observed during the dose escalation part.
– Has progressed on, is intolerant to, refused standard therapy, or there is no standard therapy that would provide clinical benefit. (No limit on prior number of lines of therapy)
– Patient has accessible archival tissue that is less than 6 months old from primary or metastatic site. Patients without available tissue will need to undergo biopsy, or if biopsy deemed unsafe, case may be discussed with the medical monitor. Additionally, will undergo an on-treatment biopsy.
– Must have at least 1 measurable lesion per RECIST 1.1
– Must have ECOG of 0 – 1.
– Must have completed previous radiotherapy at least 2 weeks prior to study start.
– Must have predicted life expectancy of at least 12 weeks per treating physician.
– Must have adequate organ function as determined by local lab tests, and lab values must be collected within 7 days prior to first dose.
– Female participant is not pregnant.
– Participants must agree to not breastfeed starting at screening, throughout the study, and for 90 days post last dose. Additionally, participants must agree to use highly effective forms of contraception and must not donate sperm from screening, while on study, and for 90 days post last dose.
– Must not participate in another interventional study while receiving ASP1002.
Additional criteria may apply and will be discussed with the study team and physician.
Exclusion Criteria:
– Weighs less than 40kg.
– Has grade 2 or higher toxicity per CTCAE that is due to prior therapies.
– Symptomatic central nervous system metastasis or uncontrolled CNS disease. (Patient with previously treated CNS mets may be eligible if they are clinically and radiologically stable for at least 4 weeks prior to study start, and are not currently on systemic steroids of 10mg prednisone or more per day)
– Patient has active autoimmune disease. Patients with type 1 diabetes, endocrinopathies, stable replacement therapy, or skin disorders such as alopecia, vitiligo, or psoriasis are allowed.
– Has myocardial infarct, or unstable angina within 6 months, or has symptomatic congestive heart failure or other clinically significant cardiac condition.
– Has QTcF of more than 470ms within 7 days of study start.
– LVEF< 45% per screening echocardiogram.
– Has known HIV infection. Patient is allowed if CD4+ T cell counts are equal to or greater than 350 cells/μL and patient has no history of AIDS defining opportunistic infections within the last 6 months.
– Positive serology testing.
– History of drug-induced pneumonitis, ILD, current pneumonitis, or prior history requiring high-dose glucocorticoids.
– Uncontrolled illness such as active infections, substance abuse or psychiatric illness, or social situations that would impact the patient’s ability to comply with study requirements.
– Prior bone marrow or solid organ transplant.
– Has had major surgery, and has not recovered, within 28 days prior to study start.
– Positive COVID-19 test within 10 days prior to study start.
– Has received any other investigational therapy, antineoplastic therapy, or immunotherapy within last 21 days.
– Requires or has received systemic steroid therapy or other immunosuppressive therapy within 14 days prior to first dose of study drug.
– Patient has discontinued prior immunomodulatory therapy due to grade 3 or higher that was immune-related and deemed life-threatening by the treating physician.
– Has other active malignancy requiring therapy.
– Has received prior anti-CD137 therapy.
– Received a live vaccine within last 28 days prior to study start.
Additional criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
