Metastatic Castration Resistant Prostate Cancer Clinical Trial
Official title:
Dose Escalation Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Single Agent IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
Verified date | January 2024 |
Source | Immunic AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).
Status | Terminated |
Enrollment | 18 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Male patients with histologically or cytologically confirmed adenocarcinoma of the prostate with no evidence of small cell or neuroendocrine features - Metastatic disease with limited therapeutic options, prior treatment with at least one next-generation hormonal agent (e.g., abiraterone, enzalutamide, apalutamide, darolutamide) and one taxane line of treatment is allowed - Progressive disease is defined as rising prostate-specific antigen (PSA) levels =2ng/mL and/or radiographic progression according to Prostate Cancer Working Group 3 (PCWG3) criteria at screening - Able and willing to comply with all study requirements for the duration of the study - Patients must sign an ICF prior to the start of any study-related procedures Exclusion Criteria: - Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 28 days prior to starting study treatment - Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with the study protocol - Malignancy within the previous 2 years with a =30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer or superficial bladder cancer - Patients receiving strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 - Chronic use of systemic steroid therapy (>1 month of >10 mg prednisone per day or equivalent, except replacement therapy) - Patients for whom biopsies cannot be taken or are not willing to undergo biopsies - Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at screening |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Institute of Cancer Research | London |
Lead Sponsor | Collaborator |
---|---|
Immunic AG |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and the grade (severity) of dose-limiting toxicities (DLTs) within 28 days after start of study treatment to identify the MTD and the RP2D | DLTs are abnormal laboratory parameters or adverse events (per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events V5.0) occurring during the DLT observation period of 28 days from treatment start, assessed as toxicities being related to IMU-935. | Within 28 days after start of study treatment | |
Primary | Number and severity of adverse events (AEs) reported according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) V5.0 | Incidence and severity of adverse events as assessed by CTCAE Version 5.0. | 6 months | |
Secondary | Proportion of patients considered responders to IMU-935 related to decline in prostate specific antigen (PSA) level | Patients with a serum prostate specific antigen (PSA) level decline of =30% from their pre-treatment level will be considered responders. | 6 months | |
Secondary | Proportion of patients considered responders to IMU-935 related to decline in circulating tumor cells (CTC) numbers | Patients showing a conversion of circulating tumor cells (CTC) from =5 cells/7.5 mL blood at Cycle 1 Day 1 (pre-dose) to =4 cells/7.5 mL blood will be considered responders. | 6 months | |
Secondary | Proportion of patients considered responders to IMU-935 related to the objective response based on the Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1 | Response rate as per RECIST V 1.1 will be evaluated centrally to identify responders. | 6 months |
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