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

Phase 1

Terminated

• Conditions: MYC Overexpression; MYC Translocation; Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia; Relapsed Non Hodgkin Lymphoma; Richter Syndrome; MYC Amplification
• Interventions: Drug: VIP152; Drug: BTKi

• Registration Number: NCT04978779
• Lead Sponsor: Vincerx Pharma, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-27
• Study Start: 2021-12-16
• Primary Completion: 2023-05-26
• Study Completion: 2023-05-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Monotherapy of VIP152	VIP152	Investigating VIP152 in a monotherapy cohort in patients with high-risk CLL and Richter Syndrome
VIP152 in combination with BTKi	VIP152	Investigating VIP152 in combination with a BTKi in patients with CLL
VIP152 in combination with BTKi	BTKi	Investigating VIP152 in combination with a BTKi in patients with CLL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 3 years	Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome
Time To Next Treatment	Up to 3 years	time from first dose to the initiation of next dose or death
Progression Free Survival	Up to 3 years	Number of Participants Without Disease Progression per iwCLL guidelines for CLL \& Lugano Classification for NHL
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
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

Trial Locations

Locations (5)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Pratia MCM Krakow; 🇵🇱 Kraków, Poland