Back to resultsA Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
Primary Purpose
Relapsed Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VIP152
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed Non Hodgkin Lymphoma focused on measuring CLL, Leukemia, CDK-9, VIP152
Eligibility 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
Sites / Locations
- University of Cincinnati Medical CenterRecruiting
- The Ohio State UniversityRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- Pratia MCM KrakowRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose escalation of VIP152 Escalation
Dose expansion of VIP152 Expansion
Arm Description
Investigating VIP152 in a dose escalation cohort in patients with CLL
Investigating VIP152 in a dose expansion cohort in patients with CLL and Richter Syndrome.
Outcomes
Primary Outcome Measures
Maximum tolerated dose
Incidence of Dose Limiting Toxicities (DLT) of VIP152
Safety and Tolerability
Number of participants with adverse events as a measure safety and tolerability
Phase 2 Dose
Recommended Phase 2 dose of VIP152 in CLL
Secondary Outcome Measures
Tumor Response
Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome
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
Progression Free Survival
Number of Participants Without Disease Progression per iwCLL guidelines for CLL & Lugano Classification for NHL
Overall Survival
Overall Survival Rate, Defined as Time Between First Dose Date and Date of Death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04978779
Brief Title
A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vincerx Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation of VIP152 Escalation
Arm Type
Experimental
Arm Description
Investigating VIP152 in a dose escalation cohort in patients with CLL
Arm Title
Dose expansion of VIP152 Expansion
Arm Type
Experimental
Arm Description
Investigating VIP152 in a dose expansion cohort in patients with CLL and Richter Syndrome.
Intervention Type
Drug
Intervention Name(s)
VIP152
Intervention Description
Weekly IV infusion (30 minute) for 21 day cycles.
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
Incidence of Dose Limiting Toxicities (DLT) of VIP152
Time Frame
End of Cycle 1/ Day 21
Title
Safety and Tolerability
Description
Number of participants with adverse events as a measure safety and tolerability
Time Frame
Up to 3 years
Title
Phase 2 Dose
Description
Recommended Phase 2 dose of VIP152 in CLL
Time Frame
End of Cycle 1/Day 21
Secondary Outcome Measure Information:
Title
Tumor Response
Description
Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome
Time Frame
Up to 3 years
Title
Duration of Response
Description
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
Time Frame
Up to 3 years
Title
Progression Free Survival
Description
Number of Participants Without Disease Progression per iwCLL guidelines for CLL & Lugano Classification for NHL
Time Frame
Up to 3 years
Title
Overall Survival
Description
Overall Survival Rate, Defined as Time Between First Dose Date and Date of Death
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincerx Clinical Trials Contact
Phone
+(1) 650-880-6676
Email
clinicaltrials@vincerx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincerx Study Director
Organizational Affiliation
Vincerx Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Site
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Site
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research site
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research site
Facility Name
Pratia MCM Krakow
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Site
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
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