Back to resultsIMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
Primary Purpose
Metastatic Castration Resistant Prostate Cancer
Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
IMU-935
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Institute of Cancer ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
IMU-935 - low dose, administered twice daily
IMU-935 - medium dose, administered twice daily
IMU-935 - high dose, administered twice daily
Arm Description
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05124795
Brief Title
IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunic AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
This is an open-label, non-randomized Phase 1 dose escalation, followed by dose expansion, study to define the safety, tolerability, biomarker change and anti-tumor activity of IMU-935 in patients with mCRPC. Throughout the study, safety, anti-tumor activity, biomarkers and IMU-935 plasma concentrations will be evaluated at regular intervals as per schedule of assessments. Disease progression will be assessed as per standard medical practice.
The dose escalation and expansion parts of the study will have the same treatment duration with similarly structured treatment cycles.
The study will consist of the following periods:
Screening Period: Approximately 28 days
Treatment Phase:
Main treatment over 3 cycles of 28 days each, extended treatment as long as patient benefits
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration Resistant Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMU-935 - low dose, administered twice daily
Arm Type
Experimental
Arm Description
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
Arm Title
IMU-935 - medium dose, administered twice daily
Arm Type
Experimental
Arm Description
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
Arm Title
IMU-935 - high dose, administered twice daily
Arm Type
Experimental
Arm Description
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
Intervention Type
Drug
Intervention Name(s)
IMU-935
Intervention Description
IMU-935 capsules
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Within 28 days after start of study treatment
Title
Number and severity of adverse events (AEs) reported according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Description
Incidence and severity of adverse events as assessed by CTCAE Version 5.0.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of patients considered responders to IMU-935 related to decline in prostate specific antigen (PSA) level
Description
Patients with a serum prostate specific antigen (PSA) level decline of ≥30% from their pre-treatment level will be considered responders.
Time Frame
6 months
Title
Proportion of patients considered responders to IMU-935 related to decline in circulating tumor cells (CTC) numbers
Description
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.
Time Frame
6 months
Title
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
Description
Response rate as per RECIST V 1.1 will be evaluated centrally to identify responders.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Mühler, MD
Phone
+49 89 2080 477 00
Email
info@imux.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. B., MD
Organizational Affiliation
Institute of Cancer Research, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cancer Research
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
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