IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

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

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).

Study Overview

• Status: Terminated
• Conditions: Metastatic Castration Resistant Prostate Cancer
• Intervention / Treatment: Drug: IMU-935

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Andreas Mühler, MD; Phone Number: +49 89 2080 477 00; Email: info@imux.com

Study Locations

• United Kingdom
  • London, United Kingdom, SM2 5PT
    • Institute of Cancer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Immunic AG
• Investigators: Principal Investigator: J. B., MD, Institute of Cancer Research, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: P1-IMU-935-CRPC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No