Study of INKmune in Patients With mCRPC (CaRe Prostate) (NCT06056791) | Clinical Trial Compass
CompletedPhase 1/2
Study of INKmune in Patients With mCRPC (CaRe Prostate)
United States12 participantsStarted 2023-11-30
Plain-language summary
This is an open-label, phase I/IIa dose escalation and expansion study of INKmune in men with mCRPC. INKmune is administered to patients intravenously over three doses, at least one-week apart. The study will consist of two stages.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male subjects over 18 years of age at time of screening.
. Blood Prostate Specific Antigen (PSA) of \>1.0 ng/ml at time of screening.
. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at time of screening.
. Histologic confirmation of adenocarcinoma prostate cancer.
. A diagnosis of progressive metastatic castrate resistant prostate cancer (mCRPC), as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3), following androgen deprivation therapy (ADT) and at least one androgen receptor signaling inhibitor, but not more than 3 therapies in addition to ADT. Progressive disease at the time of study entry as indicated by at least one of the following:
. Castrate level of testosterone of \< 50 ng/dL.
. Adequate organ function indicated by the following laboratory parameters:
. Negative screen for Human Immunodeficiency virus (HIV), Hepatitis B virus (HBV) antigen, and Hepatitis C virus (HCV). If testing was done within the past three months, there is no need to repeat testing if documentation of results is provided to the study site.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Timeframe: 2-3 years
2
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Timeframe: 2-3 years
3
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Timeframe: 2-3 years
4
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Timeframe: 2-3 years
5
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Timeframe: 2-3 years
6
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Timeframe: 2-3 years
7
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
. Diagnosis of small cell/neuroendocrine prostate cancer. Immunohistochemical staining for neuroendocrine markers (e.g., chromogranin A, neuron-specific enolase, and synaptophysin) is not sufficient to establish a small cell/neuroendocrine histology; morphologic features that are characteristic of small cell/neuroendocrine prostate cancer are required to confirm the presence of small cell/neuroendocrine prostate cancer.
. History of concurrent malignant cancer within previous 3 years, with the exception of in situ carcinomas and non-melanoma skin cancer. If diagnosis or treatment for other cancers have occurred in the last 3 years, further discussion needed.
. Uncontrolled autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis. Autoimmune conditions that are well-controlled in the opinion of the investigator must first be discussed with the Sponsor prior to enrollment.
. A requirement for daily systemic corticosteroids for any reason; or other immunosuppressive or immunomodulatory agents. Topical, nasal, modified-release oral, and/or physiologic corticosteroids may be permitted following discussion with the Sponsor.
. Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease.
. Patients with a current or recent history, as determined by the Investigator, of clinically significant, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastroenterological, or neurological disease.
. Cytotoxic chemotherapy within three weeks prior to start of study treatment (Day 1).
. Radiation therapy within two weeks prior to start of study treatment (Day 1).
8
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.