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

NCT05124795 | Terminated Phase 1 DMC

• 1 other identifier: P1-IMU-935-CRPC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Metastatic Castration Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Proportion of patients considered responders to IMU-935 related to decline in prostate specific antigen (PSA) level

  6 months

• Proportion of patients considered responders to IMU-935 related to decline in circulating tumor cells (CTC) numbers

  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

  6 months

Study Arms (3)

IMU-935 - low dose, administered twice daily

EXPERIMENTAL

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 - medium dose, administered twice daily

EXPERIMENTAL

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 - high dose, administered twice daily

EXPERIMENTAL

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

Interventions

IMU-935 DRUG

IMU-935 capsules

IMU-935 - high dose, administered twice daily; IMU-935 - low dose, administered twice daily; IMU-935 - medium dose, administered twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immunic AG: lead

Study Sites (1)

Institute of Cancer Research

London, SM2 5PT, United Kingdom

Location

Study Officials

• J. B., MD

  Institute of Cancer Research, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 18, 2021
• Study Start: December 9, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

GB (1)