Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07206056 | 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) | PHASE1 | RECRUITING | 188 | — | — | Oct 15, 2025 | Dec 1, 2030 | Jun 3, 2026 | 32 | United States, Australia +12 |
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the first 28 days of treatment with tulmimetostat and JSB462 and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. For the purpose of dose-escalation decisions, DLTs will be considered and included in the Bayesian Logistic Regression Model (BLRM).
The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics
The duration of exposure (in months) to Tulmimetostat and JSB462 (Part 1a and Part 1b) will be summarized by means of descriptive statistics
PSA50 is defined as a PSA reduction of at least 50% from baseline at 6 months confirmed by a second PSA measurement ≥ 3 weeks later.
| Arm | Type | Description |
|---|---|---|
| Part 1a: Cohort DL1A | EXPERIMENTAL | Tulmimetostat DL1 QD + JSB462 Dose 1 QD |
| Part 1a: Cohort DL1B | EXPERIMENTAL | Tulmimetostat DL1 QD + JSB462 Dose 2 QD |
| Part 1a: Cohort DL2A | EXPERIMENTAL | Tulmimetostat DL2 QD + JSB462 Dose 1 QD |
| Part 1a: Cohort DL2B | EXPERIMENTAL | Tulmimetostat DL2 QD + JSB462 Dose 2 QD |
| Part 1a: Cohort DL3A | EXPERIMENTAL | Tulmimetostat DL3 QD + JSB462 Dose 1 QD |
| Part 1a: Cohort DL3B | EXPERIMENTAL | Tulmimetostat DL3 QD + JSB462 Dose 2 QD |
| Part 1b : Arm A | EXPERIMENTAL | Tulmimetostat Dose 1 QD + JSB462 QD |
| Part 1b: Arm B | EXPERIMENTAL | Tulmimetostat Dose 2 QD + JSB462 QD |
| Part 2: Arm 1 | EXPERIMENTAL | Tulmimetostat RP2D QD + JSB462 QD |
| Part 2: Arm 2 | ACTIVE_COMPARATOR | Standard of Care at the discretion of the investigator |
| Name | Type | Description |
|---|---|---|
| Tulmimetostat DL1 QD | DRUG | Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s)) |
| Tulmimetostat DL2 QD | DRUG | Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s)) |
| Tulmimetostat DL3 QD | DRUG | Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s)) |
| Tulmimetostat Doses 1 or 2 QD | DRUG | Part 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD |
| Tulmimetostat RP2D QD | DRUG | Part 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD |
| JSB462 Dose 1 QD | DRUG | JSB462 Dose 1 QD |
| JSB462 Dose 2 QD | DRUG | JSB462 Dose 2 QD |
| JSB462 QD | DRUG | The dose of JSB462 QD will be determined based on the totality of data from Part 1a |
| Standard of Care (SoC) | DRUG | Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator |
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...