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TerminatedNCT04978779Updated Nov 18, 2023

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

A Phase 1 interventional study of VIP152 and BTKi in Relapsed Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, sponsored by Vincerx Pharma, Inc.. Terminated at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Vincerx Pharma, Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
Slow enrollment

From the registry’s dates

  • Primary completion was May 2023, 3 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • 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
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 6 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Vincerx Pharma, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Monotherapy of VIP152

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

    Drug: VIP152

  • Experimental
    VIP152 in combination with BTKi

    Investigating VIP152 in combination with a BTKi in patients with CLL

    Drug: VIP152 · Drug: BTKi

Interventions

  • DrugVIP152

    Weekly IV infusion for 28 day cycles.

  • DrugBTKi

    Taken per local prescribing information

06

What researchers measure

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

    Time frame: Up to 3 years

Secondary outcomes

  1. Overall Response Rate

    Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome

    Time frame: Up to 3 years

  2. 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

    Time frame: Up to 3 years

  3. Progression Free Survival

    Number of Participants Without Disease Progression per iwCLL guidelines for CLL \& Lugano Classification for NHL

    Time frame: Up to 3 years

  4. Assessment of pharmacokinetics (PK) of VIP152

    Maximum observed drug concentration in measured administration (Cmax) of VIP152

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1

  5. Time To Next Treatment

    time from first dose to the initiation of next dose or death

    Time frame: Up to 3 years

07

Study locations

5 sites
  • University of Cincinnati Medical Center
    Cincinnati, Ohio 45219, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
  • Pratia MCM Krakow
    Kraków, 30-510, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04978779
Lead sponsor
Vincerx Pharma, Inc.
Responsible party
Sponsor
First posted
Jul 27, 2021
Start date
Dec 16, 2021
Primary completion
May 26, 2023
Completion
May 26, 2023
Last update
Nov 18, 2023

Study contacts

Vincerx Study Director
study director · Vincerx Pharma, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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