Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-01-06 @ 2:02 AM
Study NCT ID:
NCT05124795
Status:
TERMINATED
Last Update Posted:
2024-01-17
First Post:
2021-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
Sponsor:
Immunic AG
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: