Clinical Trials /

A Phase 1 Dose-Escalation and Cohort-Expansion of VLS-101 in Hematologic Malignancies

NCT03833180

Description:

A Phase 1 Dose-Escalation Study of VLS-101 in Hematological Malignancies

Related Conditions:
  • B-Cell Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Dose-Escalation and Cohort-Expansion of VLS-101 in Hematologic Malignancies
  • Official Title: A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS -101 in Subjects With Hematological Malignancies

Clinical Trial IDs

  • ORG STUDY ID: VLS-101-0001
  • NCT ID: NCT03833180

Conditions

  • Chronic Lymphocytic Leukemia
  • Mantle Cell Lymphoma
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Diffuse Large B-cell Lymphoma
  • Richter Transformation Lymphoma
  • Burkitt Lymphoma
  • Lymphoplasmacytoid Lymphoma
  • T-cell Non-Hodgkin Lymphoma
  • Acute Lymphoid Leukemia
  • Acute Myeloid Leukemia
  • Waldenstrom Macroglobulinemia

Interventions

DrugSynonymsArms
VLS-101 Schedule 1VLS-101 Schedule 1
VLS-101 Schedule 2VLS-101 Schedule 2
VLS-101 Schedule 3VLS-101 Schedule 3

Purpose

A Phase 1 Dose-Escalation Study of VLS-101 in Hematological Malignancies

Detailed Description

      This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics,
      pharmacodynamics, immunogenicity, and efficacy of the novel drug, VLS-101, across a range of
      dose levels when administered to subjects with previously treated relapsed or refractory
      chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular
      lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma, or Richter transformation
      lymphoma, Burkitt lymphoma, lymphoplasmacytoid lymphoma, Waldenström macroglobulinemia,
      T-cell non-Hodgkin lymphoma, acute lymphoid leukemia, or acute myeloid leukemia.
    

Trial Arms

NameTypeDescriptionInterventions
VLS-101 Schedule 1ExperimentalOpen label VLS-101 at 0.5,1.0, 1.5, 2.25, 2.5, 2.75, or 3.0 mg/kg given IV on Day 1 of repeated 21-day cycles.
  • VLS-101 Schedule 1
VLS-101 Schedule 2ExperimentalOpen label VLS-101 at 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, or 2.25 mg/kg given IV on Days 1 and 8 of repeated 21-day cycles.
  • VLS-101 Schedule 2
VLS-101 Schedule 3ExperimentalOpen label VLS-101 at 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, or 2.25 mg/kg given IV on Days 1, 8, and 15 of repeated 28-day cycles.
  • VLS-101 Schedule 3

Eligibility Criteria

        Inclusion:

          -  Men or women of age ≥18 years.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

          -  Presence of measurable B-cell cancer that has progressed during or relapsed after
             prior systemic therapy.

          -  Availability of pretreatment tumor tissue.

          -  All acute toxic effects of prior antitumor therapy resolved to Grade ≤1

          -  Adequate bone marrow function

          -  Adequate hepatic profile

          -  Adequate renal function

          -  Adequate coagulation profile

          -  Negative testing for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C

          -  For female subjects of childbearing potential, a negative serum pregnancy test.

          -  For both male and female subjects, willingness to use adequate contraception

          -  Willingness and ability of the subject to comply with study activities.

          -  Evidence of a personally signed informed consent document.

        Exclusion Criteria:

          -  Presence of malignancy involving the central nervous system.

          -  Presence of another major cancer.

          -  Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.

          -  Uncontrolled ongoing infection.

          -  Pregnancy or breastfeeding.

          -  Candidacy for hematopoietic stem cell transplantation (HSCT) or chimeric antigen
             receptor (CAR)-T-cell therapy (based on investigator judgment).

          -  Evidence of graft-versus-host disease (GVHD) with Grade ≥2 serum bilirubin, Grade ≥3
             skin involvement, or Grade ≥3 diarrhea.

          -  Prior solid organ transplantation.

          -  Major surgery within 4 weeks before the start of study therapy.

          -  Prior therapy with certain excluded drugs.

          -  Ongoing immunosuppressive therapy other than corticosteroids.

          -  Use of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4.

          -  Use of a drug known to prolong the QT interval.

          -  Concurrent participation in another therapeutic or imaging clinical trial.

          -  Presence of a medical condition that (in the judgement of the investigator) interferes
             with the ability of the subject to participate in the study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose (MTD)
Time Frame:3-4 weeks
Safety Issue:
Description:Recommended starting dose and schedule

Secondary Outcome Measures

Measure:Plasma VLS-101 drug concentrations
Time Frame:Weekly during the first 3-4 weeks and then every 3-4 weeks up to 96 weeks
Safety Issue:
Description:Pharmacokinetics
Measure:Incidence of adverse events and laboratory abnormalities
Time Frame:Weekly during the first 6-8 weeks and then every 3-4 weeks up to 96 weeks
Safety Issue:
Description:Safety
Measure:Serum concentrations of VLS-101-reactive antibodies
Time Frame:Every 3-4 weeks up to 96 weeks
Safety Issue:
Description:Immunogenicity
Measure:Tumor response by published criteria
Time Frame:Every 8-12 weeks up to 48 weeks and then every 12-18 weeks up to 96 weeks
Safety Issue:
Description:Efficacy

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:VelosBio Inc.

Trial Keywords

  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Leukemia, B-Cell
  • Leukemia, Lymphoid
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, Follicular
  • Lymphoma, Mantle-Cell
  • Burkitt Lymphoma
  • Lymphoma, Lymphoplasmacytoid
  • Waldenström Macroglobulinemia
  • Lymphoma, T-cell
  • Leukemia, Lymphoid, Acute
  • Leukemia, Myeloid, Acute

Last Updated

February 12, 2020