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Trial record 1 of 1 for:    nct05124795
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IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT05124795
Recruitment Status : Recruiting
First Posted : November 18, 2021
Last Update Posted : February 1, 2023
Sponsor:
Information provided by (Responsible Party):
Immunic AG

Study Description
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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).

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer Drug: IMU-935 Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 9, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: IMU-935 - low dose, administered twice daily
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
 Drug: IMU-935
IMU-935 capsules
Experimental: IMU-935 - medium dose, administered twice daily
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
 Drug: IMU-935
IMU-935 capsules
Experimental: IMU-935 - high dose, administered twice daily
main treatment phase of 3 cycles of 28 days; followed by extended treatment cycles for patients that show clinical benefit from treatment
 Drug: IMU-935
IMU-935 capsules


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Within 28 days after start of study treatment ]
    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.

  2. Number and severity of adverse events (AEs) reported according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) V5.0 [ Time Frame: 6 months ]
    Incidence and severity of adverse events as assessed by CTCAE Version 5.0.


Secondary Outcome Measures :
  1. Proportion of patients considered responders to IMU-935 related to decline in prostate specific antigen (PSA) level [ Time Frame: 6 months ]
    Patients with a serum prostate specific antigen (PSA) level decline of ≥30% from their pre-treatment level will be considered responders.

  2. Proportion of patients considered responders to IMU-935 related to decline in circulating tumor cells (CTC) numbers [ Time Frame: 6 months ]
    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.

  3. 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 [ Time Frame: 6 months ]
    Response rate as per RECIST V 1.1 will be evaluated centrally to identify responders.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05124795


Contacts
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Contact: Andreas Mühler, MD +49 89 2080 477 00 info@imux.com

Locations
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United Kingdom
Institute of Cancer Research Recruiting
London, United Kingdom, SM2 5PT
Sponsors and Collaborators
Immunic AG
Investigators
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Principal Investigator: J. B., MD Institute of Cancer Research, United Kingdom
More Information
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Responsible Party: Immunic AG
ClinicalTrials.gov Identifier: NCT05124795    
Other Study ID Numbers: P1-IMU-935-CRPC
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases