Clinical trial NCT04978779: A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
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
Lead sponsor: Vincerx Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 3 years
measure: Duration of Response
timeFrame: Up to 3 years
measure: Progression Free Survival
timeFrame: Up to 3 years
measure: Assessment of pharmacokinetics (PK) of VIP152
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1
measure: Time To Next Treatment
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Kraków
country: Poland
facility: Pratia MCM Krakow
Study officials:
affiliation: Vincerx Pharma, Inc.
name: Vincerx Study Director
role: STUDY_DIRECTOR
References: