Phase 1 Study VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome

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Brief Title

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

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

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
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated dose

Secondary Outcome

 Tumor Response

Condition

Relapsed Non Hodgkin Lymphoma

Intervention

VIP152

Study Arms / Comparison Groups

 Dose escalation of VIP152 Escalation
Description:  Investigating VIP152 in a dose escalation cohort in patients with CLL

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

54

Start Date

December 16, 2021

Completion Date

February 2026

Primary Completion Date

February 2026

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Vincerx Study Director, +(1) 650-880-6676, [email protected]

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT04978779

Organization ID

VNC-152-102


Responsible Party

Sponsor

Study Sponsor

Vincerx Pharma, Inc.


Study Sponsor

Vincerx Study Director, Study Director, Vincerx Pharma, Inc.


Verification Date

December 2021