Trials / Terminated
TerminatedNCT04978779
A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Vincerx Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VIP152 | Weekly IV infusion for 28 day cycles. |
| DRUG | BTKi | Taken per local prescribing information |
Timeline
- Start date
- 2021-12-16
- Primary completion
- 2023-05-26
- Completion
- 2023-05-26
- First posted
- 2021-07-27
- Last updated
- 2023-11-18
Locations
5 sites across 2 countries: United States, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04978779. Inclusion in this directory is not an endorsement.