Luxdegalutamide

DRUG3 trials

Sponsors

Novartis Pharma AG

Conditions

Metastatic castrate resistant prostate cancer (mCRPC)Metastatic castration resistant prostate cancer (mCRPC)Metastatic hormone-sensitive prostate cancer

Phase 1

TulmiSTAR-01: A two-part, Phase I dose escalation and expansion followed by a randomized, open-label multicenter, Phase II study to assess the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) vs standard of care in patients with progressive metastatic castrate resistant prostate cancer

Not yet recruitingCTIS2025-521880-10-00

Novartis Pharma AGMetastatic castrate resistant prostate cancer (mCRPC)

Target: 76Updated: 2025-12-16

Phase 2

A Phase II, randomized, open-label, multi-center study of JSB462 (luxdegalutamide) in combination with abiraterone in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC)

RecruitingCTIS2024-520156-22-00

Novartis Pharma AGMetastatic hormone-sensitive prostate cancer

Start: 2025-10-08Target: 63Updated: 2025-12-05

A Phase II, randomized, open-label, multi-center study of JSB462 in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)

RecruitingCTIS2024-520155-24-00

Novartis Pharma AGMetastatic castration resistant prostate cancer (mCRPC)

Start: 2025-10-16Target: 46Updated: 2026-01-26