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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04978779
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Vincerx Pharma, Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Relapsed Non Hodgkin Lymphoma Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia Richter Syndrome MYC Amplification MYC Overexpression MYC Translocation Drug: VIP152 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Phase 1 Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Maximum Tolerated Dose of VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
Actual Study Start Date : December 16, 2021
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation of VIP152 Escalation
Investigating VIP152 in a dose escalation cohort in patients with CLL
 Drug: VIP152
Weekly IV infusion (30 minute) for 21 day cycles.
Experimental: Dose expansion of VIP152 Expansion
Investigating VIP152 in a dose expansion cohort in patients with CLL and Richter Syndrome.
 Drug: VIP152
Weekly IV infusion (30 minute) for 21 day cycles.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: End of Cycle 1/ Day 21 ]
    Incidence of Dose Limiting Toxicities (DLT) of VIP152

  2. Safety and Tolerability [ Time Frame: Up to 3 years ]
    Number of participants with adverse events as a measure safety and tolerability

  3. Phase 2 Dose [ Time Frame: End of Cycle 1/Day 21 ]
    Recommended Phase 2 dose of VIP152 in CLL


Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: Up to 3 years ]
    Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome

  2. Duration of Response [ Time Frame: Up to 3 years ]
    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

  3. Progression Free Survival [ Time Frame: Up to 3 years ]
    Number of Participants Without Disease Progression per iwCLL guidelines for CLL & Lugano Classification for NHL

  4. Overall Survival [ Time Frame: Up to 3 years ]
    Overall Survival Rate, Defined as Time Between First Dose Date and Date of Death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04978779


Contacts
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Contact: Vincerx Clinical Trials Contact +(1) 650-880-6676 clinicaltrials@vincerx.com

Locations
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United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Research Site         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Research Site         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Research site         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Research site         
Poland
Pratia MCM Krakow Recruiting
Kraków, Poland, 30-510
Contact: Research Site         
Sponsors and Collaborators
Vincerx Pharma, Inc.
Investigators
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Study Director: Vincerx Study Director Vincerx Pharma, Inc.
More Information
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Responsible Party: Vincerx Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04978779    
Other Study ID Numbers: VNC-152-102
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincerx Pharma, Inc.:
CLL
Leukemia
CDK-9
VIP152
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell