Study on NX-5948 Combined with Other Treatments for Adults with B-cell Blood Cancers
Sponsor: Nurix Therapeutics, Inc.
ClinicalTrials ID:NCT07520006
This clinical trial is testing a new drug, NX-5948, in combination with other approved treatments to see if it can help treat certain types of blood cancers, specifically chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Patient Parameters
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Program Overview
The study is exploring the use of a new drug called NX-5948, which is designed to target and destroy a protein that helps cancer cells grow in certain blood cancers like CLL and SLL. This drug will be tested in combination with other approved treatments, such as venetoclax and either rituximab or obinutuzumab. The main goals are to see how safe NX-5948 is when used with these treatments, how it behaves in the body, and how effective it is in treating CLL or SLL.
Description
NX-5948 is an experimental drug that targets a protein called Bruton tyrosine kinase (BTK), which is involved in the growth of cancer cells in blood cancers like CLL and SLL. It works by finding and destroying this protein inside the cells. In this study, NX-5948 will be used along with other approved medications: venetoclax, rituximab, and obinutuzumab, which are already used to treat CLL/SLL.
The study will focus on:
- Evaluating the safety of NX-5948 when combined with these other treatments.
- Understanding how NX-5948 interacts with the body when used with these treatments.
- Assessing how well NX-5948 works in treating CLL or SLL when used with these treatments.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Must have good organ and bone marrow function.
- Must have measurable disease as determined by a CT scan.
- For patients with relapsed or refractory CLL/SLL, previous treatment must have included a BTK inhibitor.
- For patients with first-line CLL/SLL, must have confirmed untreated CLL/SLL that requires systemic treatment.
- Must be willing to sign an informed consent form and understand the study's purpose and procedures.
Exclusion Criteria
- Cannot have a history of certain other blood cancers, like prolymphocytic leukemia or Richter's transformation.
- Cannot have received any investigational or anticancer therapy recently (within 5 half-lives or 14 days).
- Cannot have had radiotherapy within 2 weeks of starting the study, except for specific cases.
- Cannot be using high doses of systemic corticosteroids recently (within 7 days).
- Cannot have been previously treated with a BTK degrader.
- Cannot have been previously treated with a BCL-2 inhibitor unless eligible for retreatment.
- Cannot have cancer affecting the central nervous system.
- Cannot have had recent significant heart problems or events like a heart attack or stroke within 6 months.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rocky Mountain Cancer Centers | 80012 | Aurora | Colorado |
| University of Miami | 33146 | Coral Gables | Florida |
| Oncology Associates of Oregon | 97401 | Eugene | Oregon |
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology - Northeast | 75702 | Tyler | Texas |
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