A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
Phase 1
572
about 5.8 years
18+
18 sites in CA, CO, CT +11
What this study is about
This trial is testing a treatment called NX-5948 in adults with certain types of cancer. The goal is to see if it's safe and helps fight the cancer.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take NX-5948
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Number of participants with treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs), TEAEs leading to study drug discontinuation, deaths due to TEAEs, and all deaths, To establish the maximum tolerated dose and/or recommended Phase 1b dose(s), To evaluate the anti-tumor activity of NX-5948 in the dose levels selected for Phase 1b safety expansion based on overall response rate (ORR) as assessed by Investigator, To further evaluate the anti-tumor activity of NX-5948 in patients with CLL/SLL at the dose identified in Phase 1b Part 1 based on overall response rate (ORR) as assessed by Investigator
Secondary: Complete response (CR) rate / CR with incomplete marrow recovery as assessed by the Investigator, Duration of response (DOR) as assessed by the Investigator, Number of participants with treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs), TEAEs leading to study drug discontinuation, deaths due to TEAEs, and all deaths, Pharmacodynamic (PD) profile of NX-5948: Changes from baseline of BTK levels in B-cells, Pharmacokinetic (PK) profile of NX-5948: Maximum Serum Concentration, Progression-free survival (PFS) as assessed by the Investigator
Oncology