Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS -101 in Subjects With Hematological Malignancies

Details

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.

Keywords

Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Diffuse Large B-cell Lymphoma Richter Transformation Lymphoma Lymphoma Lymphoma, Non-Hodgkin Leukemia, B-Cell Leukemia, Lymphoid Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse VLS-101

Eligibility

For people ages 18 years and up

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.

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UCLA Department of Medicine - Hematology/Oncology accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VelosBio Inc.
ID
NCT03833180
Phase
Phase 1
Study Type
Interventional
Last Updated