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Also known as Tulmimetostat DL1 QD
Tulmimetostat DL1 · 1 trial · 1 indication
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...
Tulmimetostat DL1 is an investigational small molecule being studied for the treatment of progressive metastatic castrate resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Tulmimetostat DL1 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical trials for progressive metastatic castrate resistant prostate cancer.
Tulmimetostat DL1 is in Phase 1 clinical development. It is being evaluated in an open-label, active-controlled study for patients with progressive metastatic castrate resistant prostate cancer. The drug is investigational and has not received regulatory approval.
Tulmimetostat DL1 is being studied in the TulmiSTAR-01 trial (NCT07206056), an open-label, active-controlled Phase 1 dose escalation and expansion study. The trial is recruiting 188 male patients aged 18 years and older with progressive metastatic castrate resistant prostate cancer across multiple countries.
Yes, Tulmimetostat DL1 is also known as Tulmimetostat DL1 QD. Both names refer to the same investigational drug being developed by Novartis AG for progressive metastatic castrate resistant prostate cancer.
Tulmimetostat DL1 is a small molecule that belongs to the -stat class of enzyme inhibitors. It is being studied in combination with JSB462 (Luxdegalutamide) in the TulmiSTAR-01 trial for progressive metastatic castrate resistant prostate cancer.