A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients with Mature B-Cell Malignancies
Professor Chan Cheah
BeiGene
BGB-11417-101
1a/1b
Mature B-Cell Malignancies
In humans, the BCL2 gene helps regulate cell death or life. A specific protein called Bcl-2 is pro-survival, helping to keep cells alive. Some cancer cells express to much BCL-2 protein, which reduces the cells death response. Over-expression of the protein is a common finding in leukaemias and lymphomas.
This phase 1 study offers patients with mature B-Cell malignancies a tablet of BGB-11417 which is a Bcl-2 inhibitor. This drug is a 2nd generation Bcl-2 inhibitor, other Bcl-2 inhibitor currently used in lymphomas and leukaemias have shown very promising results.
Key Inclusion Criteria:
Part 1:
Marginal Zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) or transformed B-cell NHL (excluding Richters Transformation) that has relapsed or is refractory to at least 1 prior therapy
Part 2 (CLL/SLL Ramp-up):
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that relapsed or been refractory to at least 1 prior therapy
Part 2 (Expansion Cohorts):
Marginal Zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) or transformed B-cell NHL (excluding Richters Transformation) that has relapsed or is refractory to at least 1 prior therapy
Key Exclusion Criteria:
- Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate
- Known central nervous system (CNS) involvement by lymphoma/leukemia
- Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter’s syndrome
- Prior autologous stem cell transplant unless ≥ 3 months after transplant
- Prior allogeneic stem cell transplant
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
NCT04277637