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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07190300
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tulmimetostat — DRUG
    Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
  • Darolutamide — DRUG
    600 mg is administered orally BID
  • Abiraterone — DRUG
    1000 mg is administered orally QD

Study Details

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).

Key Dates

Start date
Jan 13, 2026
Status verified
Jun 2026
Primary completion
Aug 2, 2032
Completion
Aug 2, 2032

Study Design

Enrollment
181 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Group A (part 1)
    Tulmimetostat oral (PO) once a day (QD) escalating doses + Darolutamide 600 mg twice a day (BID)
  • Experimental: Phase I: Group B (part 2)
    Tulmimetostat PO QD escalating doses + Abiraterone 1000 mg PO QD
  • Experimental: Phase II: Arm 1
    Tulmimetostat dose 1 PO + Darolutamide 600 mg PO BID
  • Experimental: Phase II: Arm 2
    Tulmimetostat dose 2 PO + Darolutamide 600 mg PO BID
  • Active Comparator: Phase II: Arm 3
    Darolutamide 600 mg PO BID

Primary Outcome Measure

Phase I (Group A and Group B): Dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Univ of Alabama at BirminghamBirminghamAlabama35294-3300
Joelle Hamilton (PRINCIPAL_INVESTIGATOR)
Uni Of Iowa Hospitals And ClinicsIowa CityIowa52242
Fernando Maciel Barbosa (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer CenterWestwoodKansas66205
Katie Looney
[email protected]
Haoran Li (PRINCIPAL_INVESTIGATOR)
Wichita Urology Group PAWichitaKansas67226
Tyler Gentry
[email protected]
Timothy Richardson (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Tykeytra Dale
[email protected]
Jeffrey Shevach (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina MUSCCharlestonSouth Carolina29425
Renee Tucker
[email protected]
843-792-7560
Kevin Becker (PRINCIPAL_INVESTIGATOR)
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572
Lindsey Rabon
[email protected]
843-839-1679
Neal Shore (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer InstituteSalt Lake CityUtah84112
Alena Turner
[email protected]
Neeraj Agarwal (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
Univ of Alabama at Birmingham· Birmingham, ALUni Of Iowa Hospitals And Clinics· Iowa City, IAUniversity of Kansas Cancer Center· Westwood, KSWichita Urology Group PA· Wichita, KSDuke University Medical Center· Durham, NCMedical University of South Carolina MUSC· Charleston, SC

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