Title
Boston Biomedical BBI603-103HEM
Study Title
A phase 1b clinical study of BBI608 for adult patients with advanced, refractory hematologic malignancies
Malignancy
z- Myelodysplastic syndrome (MDS), Chronic Myeloid Leukemia (CML), Chronic lymphocytic leukemia (CLL), Acute myeloid leukemia (AML), multiple myeloma (MM), Lymphoma, SLL, DLBCL, FL, MCL, MZL, Burkitt lymphoma, Hodgkins lymphoma, NHL, HL
Investigational Agent
BBI-608 (alone or in combination)
Drug Class
Stem cell targeting small molecule inhibitor
Key Eligibility Criteria Details
- Histologically confirmed advanced, relapsed, or refractory hematologic malignancies
- Have already received currently available standard of care therapies
- No know CNS involvement
- ECOG PS 0-2 (0-1 for dose escalation phase)
- May have received auto or allo SCT
- Not currently candidate for auto or allo SCT
- No acute GVHD, but chronic GVHD allowed if not requiring steroids and GI tract not affected such that absorption of oral drugs are impared.
- Must be able to take oral medication
- For Multiple Myeloma
- Measurable disease with either serum M-protein ≥1 g/dl, urine M-protein ≥200mg/24h, or abnormal serum free light-chain ratio and abnormal light chain values
- Must have received prior tx with both immunomodulatory agent and a proteasome inhibitor
- For Lymphoma
- HL or NHL (B-cell or T-cell) relapsed or refractory to at least 1 line of prior therapy
- For AML/MDS
- Relapsed or refractory disease after at least one prior line of standard therapy
- M3 (APL) is allowed if potentially curative therapies are no longer an option
- For CML
- Must have received at least 2 lines of prior therapy, and each line must have used a standard TKI alone or in combination
- If T315I mutation is present must have received ponatinib if a candidate
- For CLL
- Must have received at least 1 line of prior therapy
Objective
Primary- Safety and tolerability; Secondary- PK profile, PD activity by biomarker analysis
