Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zanubrutinib · 1 trial · 1 indication
Determination of the RP2D of Zanubrutinib, when used in combination with Tafasitamab, based on evaluation of dose limiting toxicity (DLT) in participants during the Phase 1 part of the study. DLT will be defined as the occurrence of specified adverse events (AEs) at least possibly related to the study therapy during the DLT review period.
The complete response (CR) rate among study participants in Phase 2 to Zanubrutinib at the RP2D in combination with Tafasitamab will be assessed. Response will be assessed using positron emission tomography (PET)/computerized tomography (CT) according to the Lugano 2014 criteria. CR will be defined by a Deauville score of less than or equal to (≤) 3.
| Arm | Type | Description |
|---|---|---|
| Zanu-Tafa Phase 1 Group | EXPERIMENTAL | Participants in this group will receive combination therapy of Zanubrutinib (Zanu) and Tafasitamab (Tafa) for up to 24 cycles, followed by maintenance therapy with Zanubrutinib until progression. Each cycle is 28 days in length. Combination therapy will be administered via induction phases as follows: 1. Early induction - cycles 1 to 3 (12 weeks) 2. Late induction - cycles 4 to 12 (36 weeks) 3. Extended induction - cycles 13-24 (48 weeks) Subsequent maintenance Zanu therapy may last up to 2 years. Total study participation is up to four (4) years. |
| Zanu-Tafa Phase 2 Group | EXPERIMENTAL | Participants in this group will receive the combination therapy of Zanubrutinib (Zanu) at the recommended phase 2 dose (RP2D) determined during Phase 1, and Tafasitamab at standard doses, followed by maintenance therapy with Zanubrutinib until progression.. Combination therapy will be administered via induction phases as follows: 1. Early induction - cycles 1 to 3 (12 weeks) 2. Late induction - cycles 4 to 12 (36 weeks) 3. Extended induction - cycles 13-24 (48 weeks) Subsequent maintenance Zanu therapy may last up to 2 years. Total study participation is up to four (4) years. |
| Name | Type | Description |
|---|---|---|
| Zanubrutinib | DRUG | Participants will be administered Zanubrutinib orally (PO) via capsules daily during each 28-day cycle at the following dose levels: * Phase 1 Dose Level 1: 320 mg * Phase 1 Dose Level -1: 240 mg * Phase 2: Recommended dose determined in Phase 1. |
| Tafasitamab | DRUG | Participants will be administered a 12 mg/kg dose of Tafasitamab intravenously (IV) during each 28-day cycle as follows: * Early Induction - Cycle 1: Days 1, 4, 8, 15, and 22 * Early Induction - Cycles 2 and 3: Days 1, 8, 15 and 22 * Late Induction - Cycles 4 through 12: Days 1 and 15 |
Inclusion Criteria: 1. Men and women ≥ 18 years of age 2. Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification 3. Baseline PET/CT scans must demonstrate fluorodeoxyglucose (FDG) avid lesions compatible with CT defined...
Zanubrutinib is an investigational small molecule being studied for the treatment of Mantle Cell Lymphoma, a type of blood cancer. It is currently in Phase 1 clinical development. The drug is being evaluated in combination with tafasitamab in a clinical trial enrolling patients with this condition.
Zanubrutinib targets BTK, or Bruton's tyrosine kinase, an enzyme involved in B-cell development and signaling. It acts as a BTK inhibitor, which means it blocks the activity of this enzyme. By inhibiting BTK, the drug aims to interfere with the growth and survival of cancer cells in Mantle Cell Lymphoma.
Zanubrutinib is being developed by Incyte Corporation, a biopharmaceutical company. Incyte's stock is traded under the ticker symbol INCY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Mantle Cell Lymphoma.
Zanubrutinib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the drug in combination with tafasitamab for the treatment of Mantle Cell Lymphoma.
Zanubrutinib is being studied in a Phase 1 clinical trial with the identifier NCT06029309, titled 'Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma.' This trial is currently recruiting participants in the United States and has an enrollment target of 27 patients aged 18 years and older.
No, Zanubrutinib is not the same as tafasitamab. Zanubrutinib is a BTK inhibitor, while tafasitamab is a different drug. In the ongoing clinical trial NCT06029309, the two drugs are being studied in combination for the treatment of Mantle Cell Lymphoma.