Actively Recruiting
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)
Led by Novartis Pharmaceuticals · Updated on 2026-05-08
188
Participants Needed
30
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is an adult man 18 years of age or older.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features.
- At least one metastatic lesion visible on recent imaging within 28 days before treatment or randomization.
- Progressive metastatic castrate resistant prostate cancer.
- Castrate level of serum or plasma testosterone (less than 50 ng/dL or less than 1.7 nmol/L).
- Prior second generation androgen receptor pathway inhibitor therapy: progressed on at least one (abiraterone, enzalutamide, darolutamide, or apalutamide).
- For Part 1a: may have received up to two prior chemotherapy lines in CRPC setting; chemotherapy allowed in hormone-sensitive prostate cancer setting.
- For Part 1b: may have received up to one prior chemotherapy line in CRPC setting; chemotherapy allowed in hormone-sensitive prostate cancer setting.
- For Part 2: must be taxane-naive in mCRPC setting; prior chemotherapy allowed only in hormone-sensitive prostate cancer setting.
You will not qualify if you...
- Previous treatment with any PRC2 inhibitors, including EZH2 inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors.
- Previous treatment with protein degrader compounds targeting the androgen receptor.
- Known allergies or contraindications to study drugs or similar chemical classes.
- Treatment with any investigational agent within 28 days or 5 half-lives before study entry.
- Previous radioligand therapy in the mCRPC setting, except for Part 1a where it is allowed.
- Presence of biochemical recurrence or PSA only disease without known metastases and no need for therapy with normal PSA for at least 1 year prior.
- History of CNS metastases must be treated and stable, asymptomatic, and not on corticosteroids to maintain neurologic function.
- For CNS metastasis history, brain imaging with MRI or CT with contrast is required at baseline and follow-up.
- Other protocol-defined inclusion or exclusion criteria may apply.
AI-Screening
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Trial Site Locations
Total: 30 locations
1
Sarah Cannon Research Institute
Denver, Colorado, United States, 80218
Actively Recruiting
2
Sarah Cannon Research Institute
Jacksonville, Florida, United States, 32256
Actively Recruiting
3
Wichita Urology Group PA
Wichita, Kansas, United States, 67226
Actively Recruiting
4
Mass General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Actively Recruiting
6
Novartis Investigative Site
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
7
Novartis Investigative Site
Melbourne, Victoria, Australia, 3000
Actively Recruiting
8
Novartis Investigative Site
Liverpool, Australia, 2170
Actively Recruiting
9
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
10
Novartis Investigative Site
Beijing, China, 100021
Actively Recruiting
11
Novartis Investigative Site
Herlev, Denmark, DK-2730
Actively Recruiting
12
Novartis Investigative Site
Odense C, Denmark, 5000
Actively Recruiting
13
Novartis Investigative Site
Vejle, Denmark, DK-7100
Actively Recruiting
14
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
15
Novartis Investigative Site
Paris, France, 75015
Actively Recruiting
16
Novartis Investigative Site
Paris, France, 75231
Actively Recruiting
17
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
18
Novartis Investigative Site
Milan, MI, Italy, 20133
Actively Recruiting
19
Novartis Investigative Site
Padova, PD, Italy, 35128
Actively Recruiting
20
Novartis Investigative Site
Orbassano, TO, Italy, 10043
Actively Recruiting
21
Novartis Investigative Site
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
22
Novartis Investigative Site
Poznan, Poland, 60-192
Actively Recruiting
23
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
24
Novartis Investigative Site
Singapore, Singapore, S308433
Actively Recruiting
25
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
26
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
27
Novartis Investigative Site
Madrid, Spain, 28009
Actively Recruiting
28
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
29
Novartis Investigative Site
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
30
Novartis Investigative Site
London, United Kingdom, W1G 6AD
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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