Relapsed Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Richter Syndrome, MYC Amplification, MYC Overexpression, MYC Translocation
Conditions
Keywords
CLL, Leukemia, CDK-9, VIP152, Richter Syndrome, BTKi
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
Interventions
DRUGVIP152
Weekly IV infusion for 28 day cycles.
DRUGBTKi
Taken per local prescribing information
Sponsors
Vincerx Pharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Up to 3 years | Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Up to 3 years | Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome |
| Duration of Response | 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 |
| Progression Free Survival | Up to 3 years | Number of Participants Without Disease Progression per iwCLL guidelines for CLL & Lugano Classification for NHL |
| Assessment of pharmacokinetics (PK) of VIP152 | Cycle 1 Day 1 through Cycle 2 Day 1 | Maximum observed drug concentration in measured administration (Cmax) of VIP152 |
| Time To Next Treatment | Up to 3 years | time from first dose to the initiation of next dose or death |
Countries
Poland, United States
Outcome results
None listed