NCT05124795 is a Phase 1 clinical trial of IMU-935 in Metastatic Castration Resistant Prostate Cancer, sponsored by Immunic AG.

Who is sponsoring NCT05124795?

NCT05124795 is sponsored by Immunic AG.

What drugs are being tested in NCT05124795?

Interventions in NCT05124795: IMU-935.

What condition does NCT05124795 study?

NCT05124795 studies Metastatic Castration Resistant Prostate Cancer.

Is NCT05124795 still recruiting?

NCT05124795 is currently terminated. Last updated 17 January 2024.

Last reviewed 2024-01-17 · How we verify

NCT05124795

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 17 January 2024

What this trial tests

Phase 1 trial testing IMU-935 in Metastatic Castration Resistant Prostate Cancer in 18 participants. Terminated before completion.

Timeline

9 December 2021

Primary endpoint
31 May 2023

31 May 2023

Quick facts

Lead sponsor	Immunic AG
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	9 December 2021
Primary completion	31 May 2023
Estimated completion	31 May 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

IMU-935 — full drug profile →

Conditions studied

Metastatic Castration Resistant Prostate Cancer — all drugs for Metastatic Castration Resistant Prostate Cancer →

Sponsor

Immunic AG — full company profile →

Who can join

18 and older, male only, with Metastatic Castration Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y
An Open-label, Phase 1 Dose-finding Study of Single-agent IMU-935, a Novel RORγ/RORγt Inverse Agonist, in Patients with Progressive Metastatic Castration-resistant Prostate Cancer.
Grochot R, Guo C, Carreira S, Crespo M, et al · · 2026 · PMID 41820163 · DOI 10.1016/j.euo.2026.02.014

Verify or expand the search:

Other recruiting trials for Metastatic Castration Resistant Prostate Cancer

Currently open trials in the same condition.

NCT07093801 — Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer · recruiting
NCT06830850 — A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With · Phase 1 · recruiting
NCT06517719 — Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer · recruiting
NCT05219500 — Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate C · Phase 2 · active not recruiting
NCT04729114 — A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer · Phase 1 · recruiting

Other Immunic AG trials

Trials by the same sponsor.

NCT05054140 — Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis · Phase 2 · active not recruiting
NCT04379271 — A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of · Phase 2, PHASE3 · completed
NCT03341962 — Phase 2 Dose-finding IMU-838 for Ulcerative Colitis · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05124795 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Immunic AG
Last refreshed: 17 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05124795.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing