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This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, if the disease does not progress.
The main purpose of this study is to test if NX-5948 works to treat patients with R/R CLL/SLL. NX-5948 is a BTK degrader and works by destroying the BTK protein to stop all its actions. This is different from a BTK inhibitor which works by blocking only the kinase action of BTK. This study aims to answer these questions:
All patients in the study will receive NX-5948 orally until their cancer gets worse or if there are other reasons to stop taking NX-5948. Patients will have their cancer and other health check-ups regularly while they are taking NX-5948. If a patient's cancer has not gotten worse and they stop taking NX-5948, they will continue to have cancer check-ups until their cancer gets worse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NX-5948 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NX-5948 | Drug | Oral dose administered once daily. NX-5948 will be given in continuous 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate without partial response with lymphocytosis (PR-L) as determined by an Independent Review Committee (IRC) | The percentage of participants with response as determined according to 2018 International Workshop on CLL (iwCLL) guidelines. Response will include complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), and nodular PR. | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate with PR-L as determined by IRC | The percentage of participants with response as determined according to 2018 iwCLL guidelines. Response will include CR/CRi, PR, and nodular PR. | Up to approximately 5 years |
| Objective response rate with and without PR-L as determined by investigator |
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Inclusion Criteria:
Exclusion Criteria:
Known or suspected prolymphocytic leukemia or Richter's transformation before entering study
Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug
Palliative limited-field radiotherapy within 7 days of the first dose of study or broad field radiotherapy within 28 days of first dose of study drug
Use of systemic corticosteroids >20 mg/day prednisone or equivalent within the 7 days before start of study drug except for those used as premedication for radio diagnostic contrast
Use of systemic immunosuppressive drugs other than systemic corticosteroids within 60 days before the first dose of study drug
Previously treated with a BTK degrader
Previous chimeric antigen receptor (CAR) T-cell therapy or allogeneic or autologous hematopoietic cell transplant within the past 90 days prior to enrollment
Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage within 6 months of planned start of study drug
Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Additional Site Contact Information | Contact | 415-417-3418 | clinicaltrials@nurixtx.com |
| Name | Affiliation | Role |
|---|---|---|
| Nurix Study Director | Nurix Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| Colorado Blood Institute |
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Single Group
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The percentage of participants with response as determined according to 2018 iwCLL guidelines. Response will include CR/CRi, PR, and nodular PR. |
| Up to approximately 5 years |
| Duration of response as determined by IRC and by investigator | Time from the date of the first response to the date of documented progressive disease or death due to any cause, whichever is earlier | Up to approximately 5 years |
| Progression-free survival as determined by IRC and by investigator | Time from the date of the first dose of study drug to the date of documented progressive disease or death due to any cause, whichever is earlier | Up to approximately 5 years |
| Complete response rate as determined by IRC and by investigator | The percentage of participants with CR or CRi as determined according to 2018 iwCLL guidelines | Up to approximately 5 years |
| Time to response as determined by IRC and by investigator | Time from the start date of study treatment to the date of the first assessment of a response | Up to approximately 5 years |
| Overall survival | Time from the start date of study treatment to the date of death from any cause | Up to approximately 5 years |
| Number of participants with treatment-emergent adverse events (TEAEs), Grade 3 or higher TEAEs, serious adverse events, and TEAEs leading to study drug discontinuation | Up to approximately 3 years |
| Number of participants with clinically significant changes from baseline in laboratory parameters | Laboratory parameters may include hematology, clinical chemistry, and urinalysis | Up to approximately 3 years |
| Number of participants with clinically significant changes from baseline in vital signs | Vital signs include blood pressure, heart and respiratory rates, pulse oximetry, and temperature | Up to approximately 3 years |
| Pharmacokinetic profile of NX-5948 | NX-5948 concentrations in blood samples | Up to approximately 1 year |
| Change from baseline in Global Health Status/Quality of Life on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) | Percentage of participants with a clinically meaningful change from baseline using the EORTC QLQ-C30 questionnaire to assess the overall quality of life | Baseline and up to approximately 5 years |
| Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) | Percentage of participants with a clinically meaningful change from baseline using the EQ-5D-5L questionnaire to assess health outcomes | Baseline and up to approximately 5 years |
| Recruiting |
| Denver |
| Colorado |
| 80218 |
| United States |
| University of Miami | Recruiting | Coral Gables | Florida | 33146 | United States |
| Florida Cancer Specialists | Recruiting | Sarasota | Florida | 34232 | United States |
| Fort Wayne Oncology and Hematology | Recruiting | Fort Wayne | Indiana | 46804 | United States |
| Hematology Oncology of Indiana | Recruiting | Indianapolis | Indiana | 46260 | United States |
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
| Maryland Oncology Hematology | Recruiting | Silver Spring | Maryland | 20904 | United States |
| Karmanos Cancer Center | Recruiting | Detroit | Michigan | 48201 | United States |
| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
| Novant Health Cancer Institute | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45221 | United States |
| Oncology Hematology Care | Recruiting | Fairfield | Ohio | 45014 | United States |
| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - Center South | Recruiting | Austin | Texas | 78705 | United States |
| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
| Virginia Cancer Specialists, PC | Recruiting | Fairfax | Virginia | 22031 | United States |
| Oncology & Hematology Associates of Southwest VA | Recruiting | Norfolk | Virginia | 23502 | United States |
| Virginia Oncology Associates | Recruiting | Norfolk | Virginia | 23502 | United States |
| CHU de Nantes | Recruiting | Nantes | 44000 | France |
| Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo | Recruiting | Alessandria | 15121 | Italy |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Recruiting | Bologna | 40138 | Italy |
| Ospedale San Raffaele S.r.l. | Recruiting | Milan | 20132 | Italy |
| AUSL della Romagna UO Ematologia | Recruiting | Ravenna | 48121 | Italy |
| Pratia Hematologia Sp. z o.o. | Recruiting | Katowice | 40-519 | Poland |
| Pratia S.A. | Recruiting | Krakow | 30-225 | Poland |
| Aidport Sp. z o.o. | Recruiting | Skorzewo | 60-185 | Poland |
| Pratia Warszawa / Pratia MTZ | Recruiting | Warsaw | 02-172 | Poland |
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Headington | Oxford | OX3 9D | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Recruiting | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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