An Open-label, Multicenter Phase 1/1b Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP152 Monotherapy or Combination Therapy in Subjects With High-risk Chronic Lymphocytic Leukemia or Richter Syndrome

Vincerx Pharma, Inc.5 sites in 2 countries6 target enrollmentDecember 16, 2021

ConditionsRelapsed Non Hodgkin Lymphoma Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia Richter Syndrome MYC Amplification MYC Overexpression MYC Translocation

InterventionsVIP152 BTKi

DrugsVIP152 BTKi

Overview

Phase: Phase 1
Intervention: VIP152
Conditions: Relapsed Non Hodgkin Lymphoma
Sponsor: Vincerx Pharma, Inc.
Enrollment: 6
Locations: 5
Primary Endpoint: Safety and Tolerability
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 16, 2021

End Date

May 26, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Vincerx Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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:
•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.
•Subjects with CLL transformed to DLBCL who have relapsed after, or been refractory, to at least 1 prior line of therapy for DLBCL
•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

Arms & Interventions

Monotherapy of VIP152

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

Intervention: VIP152

VIP152 in combination with BTKi

Investigating VIP152 in combination with a BTKi in patients with CLL

Intervention: VIP152

VIP152 in combination with BTKi

Investigating VIP152 in combination with a BTKi in patients with CLL

Intervention: BTKi

Outcomes

Primary Outcomes

Safety and Tolerability

Time Frame: Up to 3 years

Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy

Secondary Outcomes

Time To Next Treatment(Up to 3 years)
Overall Response Rate(Up to 3 years)
Progression Free Survival(Up to 3 years)
Duration of Response(Up to 3 years)
Assessment of pharmacokinetics (PK) of VIP152(Cycle 1 Day 1 through Cycle 2 Day 1)