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
About this study
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.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take NX-5948
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
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