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 range18 Years
SexMALE
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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
✕. 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.
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.
Timeframe: 2-3 years
8
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
✕. 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).