WHO ICTRP trial
A study in men with advanced prostate cancer to determine the safety and effects…
EUCTR2022-002407-37-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2022-002407-37-DE |
|---|---|
| Public title | A study in men with advanced prostate cancer to determine the safety and effects of a test drug (Lutetium (177Lu) rhPSMA 10.1 injection) |
| Scientific title | An open-label, multicentre, integrated Phase 1 & 2 study to evaluate the safety, tolerability, radiation dosimetry and anti-tumour activity of Lutetium (177Lu) rhPSMA-10.1 injection in men with metastatic castrate-resistant prostate cancer |
| Primary sponsor | Blue Earth Therapeutics Limited |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Netherlands;Belgium;United States;France;Germany |
| Conditions | PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) MedDRA version: 21.1 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and… |
| Interventions | Product Name: 177Lu-rhPSMA-10.1 Pharmaceutical Form: Solution for injection INN or Proposed INN: 177Lu-rhPSMA-10.1 Other descriptive name: 177Lu-rhPSMA-10.1 Concentration unit: GBq/ml gigabecquerel/millilitre Concentration type: range… |
| Registration date | Dec 22, 2022 |
| Target size | 156 |
| Secondary IDs | BET-PSMA-121;NCT05413850 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: