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Zumsemetinib · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Phase Ib: Zunsemetinib + Capecitabine | EXPERIMENTAL | Patients will receive zunsemetinib by mouth (PO) twice per day (BID) at an assigned dose along with capecitabine (1000 mg/m\^2 PO BID on Days 1-14 an every 21-day cycle). For patients enrolled in phase Ib, capecitabine is dosed on days 2-15 during cycles 1-2. Dose escalation of zunsemetinib will utilize a 3+3 design. A maximum of 3 dose levels of zunsemetinib will be tested, and the two highest dose levels which did not lead to more than 1 of 6 patients with DLT in cycle 1 will be chosen as the RP2D-L1 and RP2D-L2 for Phase II. If only one dose level of zunsemetinib was found tolerable, then only one RP2D will be chosen for Phase II. |
| Phase II Arm 1: Standard of care anti-resorptive + Capecitabine | ACTIVE_COMPARATOR | Standard of care anti-resorptives will consist of bisphosphonate (zoledronic acid) is to be administered every 4-12 weeks, or denosumab is to be administered every 4-6 weeks, as per physician choice and institutional practice. In general, capecitabine will be taken twice daily at a dose of 1000 mg/m\^2 on Days 1 through 14 of every 21-day cycle. The first 4 patients enrolling to phase II will take capecitabine on a different schedule for PK purposes in Cycles 1 and 2 ONLY. Patients will take capecitabine at a dose of 1000mg/m\^2 on Days 2 through 15 of Cycles 1 and 2, and then on Days 1 through 14 starting with Cycle 3. |
| Phase II Arm 2: Zunsemetinib (RP2D-L1) + Capecitabine | EXPERIMENTAL | Patients will receive zunsemetinib by mouth (PO) twice per day (BID) at an assigned dose. In general, capecitabine will be taken twice daily at a dose of 1000 mg/m\^2 on Days 1 through 14 of every 21-day cycle. The first 4 patients enrolling to phase II will take capecitabine on a different schedule for PK purposes in Cycles 1 and 2 ONLY. Patients will take capecitabine at a dose of 1000mg/m\^2 on Days 2 through 15 of Cycles 1 and 2, and then on Days 1 through 14 starting with Cycle 3. |
| Phase II Arm 3: Zunsemetinib (RP2D-L2) + Capecitabine | EXPERIMENTAL | Patients will receive zunsemetinib by mouth (PO) twice per day (BID) at an assigned dose. In general, capecitabine will be taken twice daily at a dose of 1000 mg/m\^2 on Days 1 through 14 of every 21-day cycle. The first 4 patients enrolling to phase II will take capecitabine on a different schedule for PK purposes in Cycles 1 and 2 ONLY. Patients will take capecitabine at a dose of 1000mg/m\^2 on Days 2 through 15 of Cycles 1 and 2, and then on Days 1 through 14 starting with Cycle 3. If only one dose level of zunsemetinib plus capecitabine was found tolerable in phase Ib testing, the phase II trial will proceed with 2:1 two-arm randomization with Arm 2 of capecitabine plus zunsemetinib and Arm 1 of capecitabine plus standard of care anti-resorptive agent. |
| Name | Type | Description |
|---|---|---|
| Zumsemetinib | DRUG | Patients should take zunsemetinib at approximately the same times every day, with or without food with 8 oz of water. |
| Capecitabine | DRUG | Patients should take capecitabine at approximately the same times every day, within 30 minutes after a meal. |
| Zoledronic acid | DRUG | Standard of care. Will receive zoledronic acid or denosumab. |
| Denosumab | DRUG | Standard of care. Will receive zoledronic acid or denosumab. |
Inclusion Criteria for both Phase Ib and Phase II: * Hormone receptor-positive, HER2-negative metastatic breast cancer. * Measurable or non-measurable but evaluable disease by RECIST v1.1. * Candidate for capecitabine treatment per physician decision. See below phase-specific eligibility criteria f...
Zumsemetinib is an investigational small molecule being studied for the treatment of hormone receptor positive, HER-2 negative metastatic breast cancer, specifically in patients with bone metastasis. It is being evaluated in combination with capecitabine in a Phase 1 clinical trial.
Zumsemetinib is a kinase inhibitor, as indicated by its -tinib suffix. It is being studied for its potential role in treating hormone receptor positive, HER-2 negative metastatic breast cancer, though its specific molecular target has not been disclosed.
Zumsemetinib is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACRS. The company is conducting a Phase 1 clinical trial of the drug in the United States.
Zumsemetinib is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is actively recruiting participants in the United States.
Zumsemetinib is being studied in a Phase 1 clinical trial with the identifier NCT06374459. The trial is evaluating the drug in combination with capecitabine in patients with hormone receptor positive, HER-2 negative metastatic breast cancer with bone metastasis. The study is actively recruiting and aims to enroll 152 participants.