Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome
Male or female patients aged >/=18 years Adequate bone marrow, liver, and renal functions Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Diseases as defined below:
PART1
Subjects with CLL with either del(17p) by FISH or TP53 mutation who have received ≥1 prior therap(ies) and the last prior regimen must have included venetoclax plus an anti-CD20 antibody and/or a BTKi and did not produce complete remission. Subjects with CLL with either del(17p) by FISH or TP53 mutation who have received ≥2 prior regimens and are intolerant to BTKi and/or venetoclax are also eligible.
or
Subjects with CLL transformed to DLBCL who have relapsed after, or been refractory, to at least 1 prior line of therapy for DLBCL
PART2
Subjects with CLL who are currently on an approved BTKi (monotherapy only) at the dose and schedule per the local label for ≥ 12 months who have only achieved SD, PR or PRL
Exclusion Criteria:
Active clinically serious infections of Grade > 2; requiring parenteral therapy Subjects who have new or progressive brain or meningeal or spinal metastases. Anticancer chemotherapy or immunotherapy during the study or within one week prior to the first dose of study drug Major surgery or significant trauma within 4 weeks before the first dose of study drug Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment
