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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07136428 | Asciminib in HER2+ Breast Cancer Brain Metastases | PHASE1 | NOT YET_RECRUITING | 42 | — | — | Jul 1, 2026 | Nov 1, 2032 | May 6, 2026 | - | — |
Safety of administering asciminib in combination with trastuzumab by measuring number of participants with a dose-limiting toxicity at each dose level
Efficacy at maximum tolerated dose (MTD) determined by the number of participants with a complete response (CR) or partial response (PR) as determined by Response Assessment in Neuro-Oncology (RANO) Criteria for Brain Metastases (RANO-BM).
| Arm | Type | Description |
|---|---|---|
| Asciminib Trastuzumab | EXPERIMENTAL | Combination of asciminib and trastuzumab |
| Name | Type | Description |
|---|---|---|
| Asciminib and Trastuzumab | COMBINATION_PRODUCT | Each study treatment cycle will last 21 days. Asciminib will be taken orally every day during the treatment period at the dose determined as the MTD during the safety lead-in in combination with trastuzumab at a standard dose of 6mg/kg IV. Asciminib dose will begin at 80 mg daily (dose level 1), with a potential range from 40 mg daily (dose level -1A, with trastuzumab) to 200 mg bid (dose level 3, with trastuzumab) depending on the results of the safety lead-in. Trastuzumab will be given intravenously (IV) or subcutaneously (SQ) on Day 1 of each 21 day cycle. |
Inclusion Criteria: * Age ≥18 years at the time of consent * Patients with HER2+ metastatic breast cancer with at least one progressive or new brain metastasis measuring \>5mm; prior local therapy to other intracranial lesions allowed * At least 1 prior standard of care therapy for metastatic disea...