BGB-11417-101

BGB-11417-101

A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients with Mature B-Cell Malignancies

Disease:

Mature B-Cell Malignancies

Summary:

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.

Eligibility:

Include, but not limited to, the following:

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:

1. 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
2. Known central nervous system (CNS) involvement by lymphoma/leukemia
3. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
4. Prior autologous stem cell transplant unless ≥ 3 months after transplant
5. Prior allogeneic stem cell transplant

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contact person:

Haematology Cancer Trials
Email cancertrialshaem1@linear.org.au
Phone 1300 546 327


Email
Phone

Principal Investigator:

Associate Professor Chan Cheah

08 6457 7600

Sponsor:

BeiGene

Phase:

1a/1b

Protocol Number:

BGB-11417-101

Trial Registration Number:

NCT04277637

Clinical Trials.gov

ANZ Clinical Trial Registry