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NCT07190300: TulmiSTAR-02
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Phase 1, PHASE2 trial testing Tulmimetostat in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) in 155 participants. Currently enrolling.
2 August 2032
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 155 |
| Start date | 13 January 2026 |
| Primary completion | 2 August 2032 |
| Estimated completion | 2 August 2032 |
| Sites | 22 locations across France, Hong Kong, Italy, Germany, Hungary, South Korea, Australia, China |
Drugs / interventions tested
- Tulmimetostat — full drug profile →
- Darolutamide (darolutamide) — full drug profile →
- Abiraterone (ABIRATERONE) — full drug profile →
Conditions studied
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) — all drugs for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, male only, with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07190300
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tulmimetostat
Trials testing the same drug.
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- NCT05944562 — Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome · Phase 1 · active not recruiting
- NCT04104776 — A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas · Phase 1, PHASE2 · recruiting
Other recruiting trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Currently open trials in the same condition.
- NCT07181122 — Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer · recruiting
- NCT06019676 — Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients · active not recruiting
- NCT05956639 — Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC · Phase 3 · recruiting
- NCT05649943 — Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment · NA · recruiting
- NCT05683964 — Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression · EARLY_PHASE1 · active not 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 NCT07190300 (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: 8 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/NCT07190300.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing