Summary

for people ages 18 years and up (full criteria)
at UCLA UCSD
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
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 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