A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vincerx Pharma, Inc.

Criteria

Inclusion Criteria:

• Male or female patients aged >/=18 years

• Patients with a histologically or cytologically:

• Confirmed CLL who are refractory to or have progressed from 2 or more regimens including BTKi and venetoclax or

• Confirmed CLL transformed to DLBCL (Richter Syndrome) who have relapsed after, or been refractory, to at least 1 prior line of therapy for the DLBCL and having MYC overexpression/amplification/translocation

• Adequate bone marrow, liver, and renal functions

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

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