Trials / Recruiting
RecruitingNCT04830137
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 248 (estimated)
- Sponsor
- Nurix Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.
Detailed description
Phase 1a (Dose Escalation) will evaluate the safety and tolerability of NX-2127 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and for which no other therapies are known to provide clinical benefit. Phase 1b (Dose Optimization) will use a 2-stage design to further investigate the safety, tolerability, and preliminary efficacy of NX-2127 in R/R B-cell malignancies based on the dosage(s) selected in Phase 1a. Stage 1 will enroll approximately 10 participants per group based on B-cell lymphoma/leukemia indication at a specific dose selected from the first part of the study. The Sponsor may decide to open Stage 2 for any given group after review of safety and anti-tumor activity data from Stage 1. In Stage 2, an additional 10 participants will be enrolled at the dose from Stage 1 as well as 20 additional participants at a second alternative dose. Participants will be randomly assigned to one of the 2 dose levels in Stage 2.
Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Small Lymphocytic Lymphoma (SLL)
- Waldenstrom Macroglobulinemia (WM)
- Mantle Cell Lymphoma (MCL)
- Marginal Zone Lymphoma (MZL)
- Follicular Lymphoma (FL)
- Diffuse Large B-cell Lymphoma (DLBCL)
- Primary Central Nervous System Lymphoma (PCNSL)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NX-2127 | Oral NX-2127 |
Timeline
- Start date
- 2021-05-05
- Primary completion
- 2026-05-01
- Completion
- 2027-05-01
- First posted
- 2021-04-02
- Last updated
- 2026-03-20
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04830137. Inclusion in this directory is not an endorsement.