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

Vincerx Pharma

Status and phase: Terminated; Phase 1

Conditions: Refractory Chronic Lymphocytic Leukemia; MYC Translocation; MYC Overexpression; Chronic Lymphocytic Leukemia; Richter Syndrome; Relapsed Non Hodgkin Lymphoma; MYC Amplification

Treatments: Drug: VIP152; Drug: BTKi

Study type: Interventional

Funder types: Industry

Identifiers

NCT04978779

VNC-152-102

Details and patient eligibility

About

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 as monotherapy or in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Monotherapy of VIP152

Experimental group

Description:

Investigating VIP152 in a monotherapy cohort in patients with high-risk CLL and Richter Syndrome

Treatment:

Drug: VIP152

VIP152 in combination with BTKi

Experimental group

Description:

Investigating VIP152 in combination with a BTKi in patients with CLL

Treatment:

Drug: VIP152

Drug: BTKi