Carolina BioOncology Institute | Huntersville, NC
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About
ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers.
ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. It also makes the cancer cells visible to the immune system which will fight the cancer cells.
Before ASP1012 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This will help find a suitable dose for future studies and check for potential medical problems from the treatment.
In this study, ASP1012 is being tested in humans for the first time. ASP1012 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed.
People in this study will be adults whose tumor has either grown outside of the area where it started (locally advanced) or it has spread to other parts of the body (metastatic). They will receive ASP1012. Also, some people will receive ASP1012 with pembrolizumab, an approved medicine.
There are 2 main aims of this study. The first is to learn if people with certain solid tumors can tolerate different doses of ASP1012. The second is to find a suitable dose of ASP1012.
This study will be in 3 parts.
Part 1 is called Dose Escalation. People with locally advanced or metastatic tumors can take part. They will have been previously treated with all available standard cancer therapies. Different small groups of people will receive lower to higher doses of ASP1012.
For each dose, any medical problems will be recorded. This will help to find suitable doses of ASP1012 to use in Parts 2 and 3 of the study. The first group will receive the lowest dose of ASP1012. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP1012. The panel will do this for each group until all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3.
Part 2 is called Dose Expansion. 3 groups will take part: people with previously-treated melanoma (a type of skin cancer) that have not responded to their treatment (refractory) or their cancer has come back (relapsed), people with newly-diagnosed or untreated melanoma, and people with previously-treated solid tumors. People with previously-treated melanoma will receive ASP1012 at the dose worked out from Part 1. People with previously-treated solid tumors will receive ASP1012 with pembrolizumab. The first few people will receive ASP1012 at a lower dose than the dose worked out from Part 1, to check the safety of the treatments being given together. If there are no safety issues: the next people in the solid tumor group will receive ASP1012 at the dose worked out from Part 1, with pembrolizumab; also people with untreated melanoma will receive ASP1012 at the dose worked out from Part
1, with pembrolizumab.
Part 3 is also a Dose Expansion for people with other specific cancers. These are stomach cancer, ovarian cancer, or colorectal cancer. If people with certain tumors respond well in Parts 1 and 2 of the study, other people with this same type of tumor can also take part in Part 3.
For all parts of the study, ASP1012 will be given through a vein. This is called an infusion.
Each treatment cycle is 21 days long. People will start with 3 treatment cycles. People in the study may receive extra treatment cycles, if they respond well to treatment. People with melanoma who are receiving ASP1012 with pembrolizumab will not be offered the extra treatment cycles. People can stop leave the study early if: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment.
People will visit the clinic on certain days during their treatment. Some visits will be virtual or by phone. During all clinic visits, the study doctors will check for any medical problems from ASP1012. They will also check vital signs. Vital signs include temperature, pulse, breathing rate, the amount of oxygen in the blood, and blood pressure. At some visits, other checks will also include a medical examination, and an electrocardiogram (ECG) to check the heart rhythm, blood draws and urine samples for testing. A tumor sample, if available, will be taken during the first treatment cycle. People will have imaging scans and have blood draws for testing every 6 weeks during and after treatment. This will stop if they leave the study early.
People will visit the clinic within 7 days and 30 days after stopping treatment. At both visits, the study doctors will check for any medical problems from ASP1012. Other checks will include a medical examination, blood draws and urine samples for testing and checking vital signs. An ECG will also be done at the 7-day visit. After the 30-day visit, clinic staff will phone people in the study every 12 weeks to check the condition of their cancer for up to 1 year.
Enrollment
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Inclusion criteria
Participants in Parts 1 and 2 must have histologically, or cytologically, confirmed diagnosis of locally advanced or metastatic solid tumor(s).
Note: Participants with acral lentiginous melanoma will be excluded.
Participants in Part 3 (Dose Expansion) must have histologically, or cytologically confirmed diagnosis of either:
Participant has measurable disease as determined by RECIST v1.1, except for participants with CRC and ovarian cancer enrolled in Part 3. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Participant has progressed, relapsed or discontinued for toxicity during or after the last systemic anti-neoplastic therapy and is unlikely to achieve clinical benefit from standard of care therapies per investigator, except for Part 2 participants with treatment-naïve melanoma and Part 3 (participants with CRC and ovarian cancer). There is no limit to the number of prior anti-neoplastic therapies received.
Participant has a predicted life expectancy ≥ 12 weeks.
Participant has at least 1 site of disease suitable for biopsy (except for Part 3 [participants with CRC and ovarian cancer]) and is willing and able to undergo required tumor biopsies according to the treating institution's guidelines at screening and during study treatment. Bone biopsies are not acceptable.
Participant has an ECOG performance status of 0 or 1.
Female participant:
Male participant:
Participant must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
Participant agrees not to participate in another interventional study while receiving ASP1012 in the present study/participating in the present study.
Exclusion criteria
Participant has ongoing toxicity ≥ Grade 2 per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 considered clinically significant and attributable to prior anti-neoplastic therapies. Note: Participants with peripheral neuropathy, type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy or skin disorders (for example, vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.
Participant has had major surgery ≤ 4 weeks of signing the informed consent form (ICF).
Participant has symptomatic or untreated central nervous system metastases or leptomeningeal disease. Participants with treated symptomatic brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to screening) and off steroids for at least 2 weeks prior to first administration of ASP1012.
Participant has active or prior autoimmune or inflammatory disorders requiring systemic therapy within the past 2 years (including inflammatory skin conditions, or inflammatory bowel disease [for example, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, systemic lupus erythematosus, non-infectious pneumonitis, Sarcoidosis syndrome, Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion:
Participant with eczema or history of eczema requiring systemic treatment.
Participant with another malignancy that currently requires treatment
Participant with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of ASP1012. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
Participant has received a prior allogeneic bone marrow or solid organ transplant.
Participant has a condition requiring use of anti-viral agents with a potential to inhibit vaccinia replication. Prophylactic use of anti-viral agents (e.g., acyclovir) is permitted.
Participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, any form of substance abuse or psychiatric illness/social situations that would limit compliance with study visits or requirements or a condition that could invalidate communication.
Participant has a known history of human immunodeficiency virus (HIV) infection or suffers from other acquired and congenital immunodeficiency diseases. HIV testing is not required for the purposes of this study unless mandated by local health authority.
Participant has a history of moderate to severe ascites, clinically significant and/or rapidly accumulating ascites, bleeding esophageal varices, hepatic encephalopathy or pericardial and/or pleural effusions related to liver insufficiency.
Participant has a clinically significant abnormal ECG at screening that imposes a safety risk for participation in the study.
Participant has symptomatic cardiovascular disease within the preceding 12 months including but not limited to the following: significant coronary artery disease (for example, requiring angioplasty or stenting), acute myocardial infarction or unstable angina pectoris < 3 months prior to screening, uncontrolled hypertension, clinically significant arrhythmia or congestive heart failure (New York Heart Association grade ≥ 2), pericarditis or myocarditis < 3 months prior to screening.
Prior/Concomitant Therapy
Prior/Concurrent Clinical Study Experience
Diagnostic Assessments
Participant with inadequate organ and marrow functions meeting any of the below criteria:
Participant has any of the following per screening serology test:
Positive coronavirus 2019 antigen test 10 days prior to cycle 1 day 1 (C1D1) with ASP1012
Other Exclusion Criteria
Primary purpose
Allocation
Interventional model
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229 participants in 8 patient groups
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Central trial contact
Astellas Pharma Global Development, Inc.
Data sourced from clinicaltrials.gov
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