Trial · NCT07190300
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)
NCT07190300, Phase 1, Phase 2, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT07190300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07190300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT07190300
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 181 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Interventions
- Tulmimetostat, Darolutamide, Abiraterone, Prednisone/Prednisolone, Androgen Deprivation Therapy (ADT)
- First posted
- 2025-09-24
- Last updated
- 2026-09-29
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I (Group A and Group B): Dose-limiting toxicities (DLTs) | From the first dose of study treatment through the end of Cycle 1, up to 28 days | A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value that was not clearly attributable to the underlying disease or an extraneous cause, occurred during the first 28 days of treatment with tulmimetostat, and met the protocol-defined dose-limiting toxicity criteria. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Dose-limiting toxicities were included in the Bayesian Logistic Regression Model used to support dose-escalation decisions. |
| Primary | Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months | The incidence, type, frequency, seriousness, and severity of adverse events and serious adverse events will be summarized. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. |
| Primary | Phase I (Group A and Group B): Number of Participants with dose adjustments | From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months | The number of participants with dose reductions, dose interruptions, or permanent discontinuations, including the reasons for the dose adjustments, will be summarized by treatment group and dose cohort. |
| Primary | Phase I (Group A and Group B): Dose Intensity | From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months | Dose intensity, calculated as the actual cumulative dose received divided by the actual duration of exposure, and relative dose intensity, calculated as the dose intensity divided by the planned dose intensity, will be summarized using descriptive statistics for each study drug. |
| Primary | Phase I (Group A and Group B): Duration of exposure to each study drug | From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months | The duration of exposure, in months, to each study drug will be summarized using descriptive statistics by treatment group and dose cohort. |
| Primary | Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL at Month 6 | At Month 6, with confirmation by a second prostate-specific antigen assessment performed at least 3 weeks later | Prostate-Specific Antigen (PSA) response rate is defined as the proportion of participants who achieved a prostate-specific antigen level below 0.2 ng/mL at Month 6, confirmed by a second prostate-specific antigen assessment performed at least 3 weeks later. |
| Secondary | Phase I (Group A): Plasma concentrations of Tulmimetostat and Darolutamide | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days | Plasma concentrations of tulmimetostat and darolutamide will be evaluated using pharmacokinetic samples collected from participants across the evaluated dose levels in Phase I, Group A. |
| Secondary | Phase I (Group A): AUC of Tulmimetostat and Darolutamide | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days | The area under the concentration-time curve from time zero to the last quantifiable concentration, the area under the concentration-time curve from time zero extrapolated to infinity, and the area under the concentration-time curve over a dosing interval at steady state will be derived, as applicable, and summarized using descriptive statistics. |
| Secondary | Phase I (Group A): Maximum Observed Plasma Concentration (Cmax) of Tulmimetostat and Darolutamide | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days | The maximum observed plasma concentration of tulmimetostat and darolutamide will be derived, as applicable, and summarized using descriptive statistics. |
| Secondary | Phase I (Group B): Plasma concentrations of Tulmimetostat and Abiraterone | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days. | Plasma concentrations of tulmimetostat and abiraterone will be evaluated using pharmacokinetic samples collected from participants across the evaluated dose levels in Phase I, Group B. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07190300
GET https://conductscience.org/api/trials/v1/NCT07190300/registered?page=2