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Also known as asciminib, Asciminib
Asciminib and Trastuzumab · 1 trial · 1 indication
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...
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Asciminib is an investigational small molecule being studied for chronic myelogenous leukemia, including Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, and for HER2+ metastatic breast cancer. It is also being studied in patients with renal impairment. Asciminib is not approved and remains in clinical development.
Asciminib is a kinase inhibitor, belonging to the -nib class of drugs. It is being studied in chronic myelogenous leukemia and other conditions where kinase signaling plays a role. The specific molecular target is not disclosed in available information.
Asciminib is developed by Novartis AG, a pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical trials of Asciminib across multiple countries.
Asciminib has completed Phase 1, Phase 2, and Phase 3 trials. A Phase 3 study compared Asciminib to bosutinib in patients with chronic myelogenous leukemia previously treated with two or more tyrosine kinase inhibitors. Asciminib remains investigational and is not FDA approved.
Asciminib has been studied in several completed trials. NCT02081378 was a Phase 1 study in chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. NCT03106779 was a Phase 3 trial versus bosutinib. NCT03605277 examined pharmacokinetics in renal impairment, and NCT04795427 was a Phase 2 study in China.
Asciminib is not the same as Trastuzumab. Asciminib is a small molecule kinase inhibitor, while Trastuzumab is a different type of agent. Asciminib is being studied for chronic myelogenous leukemia and HER2+ metastatic breast cancer, though the two drugs are distinct.