An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)

Recruiting Phase 1 Phase 2 Interventional Study
Progressive Metastatic Castrate Resistant Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
188 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
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About This Trial

This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * Participant is an adult man ≥ 18 years of age. * Participant must have histologically and/or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features (current or prior biopsy of the prostate and/or metastatic site). * Participant…
Contacts

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

CONTACT

Novartis Pharmaceuticals

+41613241111

novartis.email@novartis.com

CONTACT