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

NCT04978779 | Terminated Phase 1 FDA Drug

• 1 other identifier: VNC-152-102
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 5

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

Conditions

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

Keywords

CLL; Leukemia; CDK-9; VIP152; Richter Syndrome; BTKi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Response Rate

  Up to 3 years

• Duration of Response

  Up to 3 years

• Progression Free Survival

  Up to 3 years

• Assessment of pharmacokinetics (PK) of VIP152

  Cycle 1 Day 1 through Cycle 2 Day 1

• Time To Next Treatment

  Up to 3 years

Study Arms (2)

Monotherapy of VIP152

EXPERIMENTAL

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

Drug: VIP152

VIP152 in combination with BTKi

EXPERIMENTAL

Investigating VIP152 in combination with a BTKi in patients with CLL

Drug: VIP152; Drug: BTKi

Interventions

VIP152 DRUG

Weekly IV infusion for 28 day cycles.

Monotherapy of VIP152; VIP152 in combination with BTKi

BTKi DRUG

Taken per local prescribing information

VIP152 in combination with BTKi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vincerx Pharma, Inc.: lead

Study Sites (5)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Pratia MCM Krakow

Krakow, 30-510, Poland

Location

Related Publications (1)

• Frigault MM, Mithal A, Wong H, Stelte-Ludwig B, Mandava V, Huang X, Birkett J, Johnson AJ, Izumi R, Hamdy A. Enitociclib, a Selective CDK9 Inhibitor, Induces Complete Regression of MYC+ Lymphoma by Downregulation of RNA Polymerase II Mediated Transcription. Cancer Res Commun. 2023 Nov 9;3(11):2268-2279. doi: 10.1158/2767-9764.CRC-23-0219.

  PMID: 37882668 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincerx Study Director

  Vincerx Pharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 27, 2021
• Study Start: December 16, 2021
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (4); PL (1)