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NCT04116164
Safety and Targeting of Anti-hk2 Antibody in mCRPC
EARLY_PHASE1 trial testing 111In-DOTA-h11B6 in Castration-Resistant Prostatic Cancer in 27 participants. Terminated before completion.
6 July 2023
Quick facts
| Lead sponsor | SpectronRX |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 27 |
| Start date | 18 September 2019 |
| Primary completion | 6 July 2023 |
| Estimated completion | 6 July 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 111In-DOTA-h11B6 — full drug profile →
Conditions studied
- Castration-Resistant Prostatic Cancer — all drugs for Castration-Resistant Prostatic Cancer →
- Metastatic Disease — all drugs for Metastatic Disease →
Sponsor
SpectronRX — full company profile →
Who can join
18 and older, male only, with Castration-Resistant Prostatic Cancer or Metastatic Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an imaging trial, to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC. This imaging study will be conducted to confirm the safety and estimate the mass amount of antibody h11B6, and confirm in vivo tumor targeting of the antibody, using Indium-111 (111In) radiolabeled h11B6 in subjects with advanced prostate cancer. This study will also provide the dosimetric information crucial for Phase 1 therapy.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Role of Theranostics in Prostate Cancer.
O'Dwyer E, Bodei L, Morris MJ. · · 2021 · cited 23× · PMID 33246638 · DOI 10.1016/j.semradonc.2020.07.004 -
Novel Agents and Future Perspectives on Theranostics.
Solnes LB, Shokeen M, Pandit-Taskar N. · · 2021 · cited 12× · PMID 33246639 · DOI 10.1016/j.semradonc.2020.07.010 -
A Phase 0 Study to Assess the Biodistribution and Pharmacokinetics of a Radiolabeled Antibody Targeting Human Kallikrein 2 in Participants with Metastatic Castration-Resistant Prostate Cancer.
Pandit-Taskar N, O'Donoghue JA, Chetty D, Max S, et al · · 2024 · cited 6× · PMID 38782459 · DOI 10.2967/jnumed.124.267416
Verify or expand the search:
- PubMed search for NCT04116164
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Castration-Resistant Prostatic Cancer
Currently open trials in the same condition.
- NCT06863272 — A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Re · Phase 1, PHASE2 · recruiting
- NCT04104607 — The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma · Phase 1 · recruiting
- NCT03748641 — A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone fo · Phase 3 · active not recruiting
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 NCT04116164 (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 SpectronRX
- Last refreshed: 25 September 2023
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/NCT04116164.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing