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

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ClinicalTrials.gov Identifier: NCT03833180
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
VelosBio Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Diffuse Large B-cell Lymphoma Richter Transformation Lymphoma Drug: VLS-101 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of VLS-101 using a standard 3+3 dose-escalation design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS -101 in Subjects With Hematological Malignancies
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: VLS-101
Open label VLS-101 at up to six dose levels of 0.5,1.0, 1.5, 2.25, 3.0, and 4.0 mg/kg.
Drug: VLS-101
Open-Label VLS-101




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: 3 weeks ]
    Recommended starting dose


Secondary Outcome Measures :
  1. Plasma VLS-101 drug concentrations [ Time Frame: Weekly during the first 3 weeks and then every 3 weeks up to 96 weeks ]
    Pharmacokinetics

  2. Incidence of adverse events and laboratory abnormalities [ Time Frame: Weekly during the first 6 weeks and then every 3 weeks up to 96 weeks ]
    Safety

  3. Serum concentrations of VLS-101-reactive antibodies [ Time Frame: Weekly during the first 3 weeks and then every 3 weeks up to 96 weeks ]
    Immunogenicity

  4. Tumor response by published criteria (Hallek 2008, Cheson 2014) [ Time Frame: Every 9 to 12 weeks up to 48 weeks and then every 12 to 16 weeks up to 96 weeks ]
    Efficacy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833180


Contacts
Contact: Elizabeth M Schmidt 2063005215 LSchmidt@velosbio.com
Contact: Langdon L Miller, MD 9089066471 lmiller@velosbio.com

Locations
United States, New York
Weill Cornell Medical College - New York - Presbyterian Hospital Recruiting
New York, New York, United States, 10065
Contact: Christine Tran    212-746-6738    cht2328@med.cornell.edu   
Sponsors and Collaborators
VelosBio Inc.
Investigators
Study Director: Langdon L Miller, MD VelosBio Inc.

Responsible Party: VelosBio Inc.
ClinicalTrials.gov Identifier: NCT03833180     History of Changes
Other Study ID Numbers: VLS-101-0001
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VelosBio Inc.:
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Follicular
Lymphoma, Mantle-Cell

Additional relevant MeSH terms:
Lymphoma
Leukemia
Lymphoma, Follicular
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell