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NCT05458544: LUCIDA
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
Phase 1, PHASE2 trial testing [177Lu]Ludotadipep 3.7 GBq in Metastatic Castration-resistant Prostate Cancer in 26 participants. Currently enrolling.
1 June 2025
Quick facts
| Lead sponsor | FutureChem |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 1 September 2022 |
| Primary completion | 1 June 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- [177Lu]Ludotadipep 3.7 GBq — full drug profile →
Conditions studied
- Metastatic Castration-resistant Prostate Cancer — all drugs for Metastatic Castration-resistant Prostate Cancer →
Sponsor
FutureChem — 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
Phase 1: The objective of the Phase 1 part of the clinical trial is to verify safety and tolerability (dose-limiting toxicity \[DLT\], maximum tolerated dose \[MTD\]) of a single 3.7 Giga-Becquerel (GBq) dose with the potential for one dose level de-escalation to 2.775 GBq if necessary, to determine the recommended \[177Lu\]Ludotadipep dose for use in the Phase 2a part of the trial. Phase 2a: The objective of the Phase 2a part of the trial is to evaluate safety and efficacy for repeated administration of the recommended \[177Lu\]Ludotadipep dose. The Recommended Phase 2 dose (RP2D) will be based on the study results from the Phase 1 trial in South Korea upon consultation with the FDA.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Status of PSMA-targeted radioligand therapy in prostate cancer: current data and future trials.
Jang A, Kendi AT, Sartor O. · · 2023 · cited 63× · PMID 36895851 · DOI 10.1177/17588359231157632 -
Peptide Drug Conjugates and Their Role in Cancer Therapy.
Heh E, Allen J, Ramirez F, Lovasz D, et al · · 2023 · cited 54× · PMID 36614268 · DOI 10.3390/ijms24010829 -
Current Status and Future Perspectives of Nuclear Medicine in Prostate Cancer from Imaging to Therapy: A Comprehensive Review.
Lee J, Kim T. · · 2025 · cited 4× · PMID 40426959 · DOI 10.3390/biomedicines13051132
Verify or expand the search:
- PubMed search for NCT05458544
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Castration-resistant Prostate Cancer
Currently open trials in the same condition.
- NCT07142551 — Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response · Phase 2 · recruiting
- NCT07288359 — Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and · Phase 1, PHASE2 · recruiting
- NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer ( · Phase 1 · recruiting
- NCT07213674 — A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic · Phase 3 · recruiting
- NCT07189403 — A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resist · Phase 1 · recruiting
Other FutureChem trials
Trials by the same sponsor.
- NCT05579184 — [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2 · Phase 2 · active not recruiting
- NCT05004285 — Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis · Phase 3 · active not recruiting
- NCT04509557 — [177Lu]Ludotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer. · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05458544 (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 FutureChem
- Last refreshed: 29 April 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/NCT05458544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing