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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03833180
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : August 30, 2019
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.

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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 ]

  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 ]

  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 ]

  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • 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 identifier (NCT number): NCT03833180

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Contact: Elizabeth M Schmidt 2063005215
Contact: Langdon L Miller, MD 9089066471

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United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Osbaldo Rodriguez, BS    626-218-9108   
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Kimberly Aguilar    858-534-5201   
United States, New York
Northwell Health/CLL Research and Treatment Program Recruiting
New Hyde Park, New York, United States, 11042
Contact: Eunok Kwak, RN    718-470-4046   
Weill Cornell Medical College - New York - Presbyterian Hospital Recruiting
New York, New York, United States, 10065
Contact: Christine Tran    212-746-6738   
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Andrew Bui    585-276-4405   
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Stephen Monette, MHA    503-494-9455   
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Maria Badillo, MSN RN OCN CCRP    7137452714   
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Ngan Trinh    206-215-2363   
Sponsors and Collaborators
VelosBio Inc.
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Study Director: Langdon L Miller, MD VelosBio Inc.

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Responsible Party: VelosBio Inc. Identifier: NCT03833180     History of Changes
Other Study ID Numbers: VLS-101-0001
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VelosBio Inc.:
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, B-Cell
Lymphoma, B-Cell