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NCT06991556
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Phase 2 trial testing JSB462 in Metastatic Hormone-sensitive Prostate Cancer in 150 participants. Currently enrolling.
29 March 2032
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 7 July 2025 |
| Primary completion | 29 March 2032 |
| Estimated completion | 19 October 2035 |
| Sites | 63 locations across France, Italy, Netherlands, Taiwan, Germany, Poland, South Korea, Canada |
Drugs / interventions tested
- JSB462 — full drug profile →
- Abiraterone (ABIRATERONE) — full drug profile →
- Enzalutamide (enzalutamide) — full drug profile →
Conditions studied
- Metastatic Hormone-sensitive Prostate Cancer — all drugs for Metastatic Hormone-sensitive Prostate Cancer →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, male only, with Metastatic Hormone-sensitive Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06991556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of JSB462
Trials testing the same drug.
- NCT07174063 — A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer · Phase 1 · recruiting
- NCT07047118 — A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration R · Phase 2 · active not recruiting
Other recruiting trials for Metastatic Hormone-sensitive Prostate Cancer
Currently open trials in the same condition.
- NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
- NCT06874114 — An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadia · active not recruiting
- NCT06334120 — An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea · recruiting
- NCT05901649 — A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation · active not recruiting
- NCT05818683 — A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer · Phase 1 · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet 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 NCT06991556 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 16 April 2026
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/NCT06991556.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing