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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04978779
• Other study ID #: VNC-152-102
• Status: Terminated
• Phase: Phase 1
• Start date: December 16, 2021
• Est. completion date: May 26, 2023

Study information

• Verified date: November 2023
• Source: Vincerx Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• MYC Translocation
• Refractory Chronic Lymphocytic Leukemia
• Relapsed Non Hodgkin Lymphoma
• Richter Syndrome
• Syndrome

Intervention

Drug:
• VIP152
Weekly IV infusion for 28 day cycles.
• BTKi
Taken per local prescribing information

Locations

Country	Name	City	State
Poland	Pratia MCM Krakow	Kraków
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vincerx Pharma, Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy	Up to 3 years
Secondary	Overall Response Rate	Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome	Up to 3 years
Secondary	Duration of Response	Time at Which Response Criteria are Met for Complete Response or Partial Response (Whichever Occurs First) Until the First Date of Recurrence, Progression or Death per applicable response criteria	Up to 3 years
Secondary	Progression Free Survival	Number of Participants Without Disease Progression per iwCLL guidelines for CLL & Lugano Classification for NHL	Up to 3 years
Secondary	Assessment of pharmacokinetics (PK) of VIP152	Maximum observed drug concentration in measured administration (Cmax) of VIP152	Cycle 1 Day 1 through Cycle 2 Day 1
Secondary	Time To Next Treatment	time from first dose to the initiation of next dose or death	Up to 3 years