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.
Patients must be ≥ 18 years of age
Patients must have measurable disease per disease-specific response criteria
Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, Lugano Classification of Lymphoma response criteria, or International PCNSL Collaborative Group response criteria)
Patients with transformed lymphoma are eligible for the study with the exception of those detailed in
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (non-PCNSL indications) or 0 - 2 (PCNSL patients)
Adequate organ and bone marrow function
Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol
Have histologically confirmed R/R CLL, SLL, WM, MCL, and MZL, FL, DLBCL, or PCNSL
Sequential
NX-2127
DrugOral NX-2127
11
Treatment groupsSee each treatment group below.
Number of Participants with Protocol Specified Dose-Limiting Toxicities
Phase 1a
To establish the MTD and/or recommended Phase 1b dosage(s) of NX-2127
Phase 1a
To evaluate the clinical activity of NX-2127 at the recommended Phase 1b dosage(s) based on overall response rate (ORR) as assessed by the Investigator
Phase 1b
Number of Participants with Adverse Events and Clinical Laboratory Abnormalities
Phase 1a/1b
Pharmacokinetic (PK) Profile of NX-2127: Maximum Serum Concentration
Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment
Duration of response (DOR) as assessed by the Investigator
Phase 1a/1b
Progression-free survival (PFS) as assessed by the Investigator
Phase 1a/1b
Overall survival (OS) as assessed by the Investigator
Phase 1b
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