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

Sponsor

Vincerx Pharma, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04978779

Collaborator

(none)

Enrollment

Locations

Arms

49.5

Anticipated Duration (Months)

10.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome

Condition or Disease	Intervention/Treatment	Phase
Relapsed Non Hodgkin Lymphoma Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia Richter Syndrome MYC Amplification MYC Overexpression MYC Translocation	Drug: VIP152	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Multicenter Phase 1 Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Maximum Tolerated Dose of VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome

Actual Study Start Date :

Dec 16, 2021

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalation of VIP152 Escalation Investigating VIP152 in a dose escalation cohort in patients with CLL	Drug: VIP152 Weekly IV infusion (30 minute) for 21 day cycles.
Experimental: Dose expansion of VIP152 Expansion Investigating VIP152 in a dose expansion cohort in patients with CLL and Richter Syndrome.	Drug: VIP152 Weekly IV infusion (30 minute) for 21 day cycles.

Arm

Intervention/Treatment

Experimental: Dose escalation of VIP152 Escalation

Investigating VIP152 in a dose escalation cohort in patients with CLL

Drug: VIP152

Weekly IV infusion (30 minute) for 21 day cycles.

Experimental: Dose expansion of VIP152 Expansion

Investigating VIP152 in a dose expansion cohort in patients with CLL and Richter Syndrome.

Drug: VIP152

Weekly IV infusion (30 minute) for 21 day cycles.

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose [End of Cycle 1/ Day 21]
Incidence of Dose Limiting Toxicities (DLT) of VIP152
Safety and Tolerability [Up to 3 years]
Number of participants with adverse events as a measure safety and tolerability
Phase 2 Dose [End of Cycle 1/Day 21]
Recommended Phase 2 dose of VIP152 in CLL

Secondary Outcome Measures

Tumor Response [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
Overall Survival [Up to 3 years]
Overall Survival Rate, Defined as Time Between First Dose Date and Date of Death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients aged >/=18 years
Patients with a histologically or cytologically:
Confirmed CLL who are refractory to or have progressed from 2 or more regimens including BTKi and venetoclax or
Confirmed CLL transformed to DLBCL (Richter Syndrome) who have relapsed after, or been refractory, to at least 1 prior line of therapy for the DLBCL and having MYC overexpression/amplification/translocation
Adequate bone marrow, liver, and renal functions
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
2	The Ohio State University	Columbus	Ohio	United States	43210
3	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
4	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
5	Pratia MCM Krakow	Kraków		Poland	30-510