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Relapsed Non Hodgkin LymphomaPhase 1NCT04978779

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

A Phase 1 study testing VIP152 and BTKi in people with Relapsed Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Vincerx Pharma, Inc. at 5 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VIP152 and BTKi
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
5 sitesin 2 countries
Study dates
16 Dec 2021to 26 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • The Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

Poland1 site

  • Pratia MCM Krakow

    Krakow, 30-510

Other trials in Poland

About this study

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

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

Being tested
VIP152, BTKi
Keywords
CLL, Leukemia, CDK-9, VIP152, Richter Syndrome, BTKi
Medical subject headings
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIP152Drug

    Weekly IV infusion for 28 day cycles.

  • BTKiDrug

    Taken per local prescribing information

Study groups in NCT04978779
Study groupRoleWhat they receive
Monotherapy of VIP152ExperimentalInvestigating VIP152 in a monotherapy cohort in patients with high-risk CLL and Richter Syndrome
Receives: Drug: VIP152
VIP152 in combination with BTKiExperimentalInvestigating VIP152 in combination with a BTKi in patients with CLL
Receives: Drug: VIP152; Drug: BTKi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Overall Response Rate

    Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome

    Measured: Up to 3 years

  2. Duration of Response

    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

    Measured: Up to 3 years

  3. Progression Free Survival

    Number of Participants Without Disease Progression per iwCLL guidelines for CLL \& Lugano Classification for NHL

    Measured: Up to 3 years

  4. Assessment of pharmacokinetics (PK) of VIP152

    Maximum observed drug concentration in measured administration (Cmax) of VIP152

    Measured: Cycle 1 Day 1 through Cycle 2 Day 1

  5. Time To Next Treatment

    time from first dose to the initiation of next dose or death

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start16 Dec 2021
  3. Primary completion26 May 2023
  4. Study completion26 May 2023

Why it stopped: Slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04978779
Sponsor's protocol ID
VNC-152-102
Status last verified
Nov 2023
First submitted
15 Jul 2021
Last updated
18 Nov 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Frigault MM, Mithal A, Wong H, Stelte-Ludwig B, Mandava V, Huang X, Birkett J, Johnson AJ, Izumi R, Hamdy A. Enitociclib, a Selective CDK9 Inhibitor, Induces Complete Regression of MYC+ Lymphoma by Downregulation of RNA Polymerase II Mediated Transcription. Cancer Res Commun. 2023 Nov 9;3(11):2268-2279. doi: 10.1158/2767-9764.CRC-23-0219.

    PubMed 37882668

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VIP152 and BTKi in people with Relapsed Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Vincerx Pharma, Inc. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04978779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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