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A Study of VLS-101 in Patients With Solid Tumors

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: NCT04504916
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : December 24, 2020
Information provided by (Responsible Party):
VelosBio Inc.

Brief Summary:
This is a Phase 2 study evaluating the efficacy, safety, pharmacokinetics, immunogenicity, and pharmacodynamics of VLS-101 in patients with metastatic solid tumors. VLS-101 is an antibody- drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1) on cancer cells.

Condition or disease Intervention/treatment Phase
Triple-negative Breast Cancer (TNBC) Non-squamous Non-small-cell Lung Cancer (NSCLC) Estrogen Receptor-positive Breast Cancer Progesterone Receptor-positive Breast Cancer Human Epidermal Growth Factor 2 Positive Carcinoma of Breast Drug: VLS-101 Phase 2

Detailed Description:

ROR1 is a cell-surface protein that has an important role in the formation of the nervous systems, bones, and blood vessels during the early development of the embryo. ROR1 disappears by the time of birth and is not detected on normal human tissues in childhood or adulthood. However, ROR1 can reappear on malignant tissues, including on hematologic cancers. This selective expression of ROR1 on cancerous cells but not on normal cells offers the potential for using VLS-101 to specifically kill the cancer cells while sparing normal cells.

VLS-101 is an investigational drug consisting of a monoclonal antibody that binds to ROR1 coupled with a potent toxin called monomethyl auristatin E (MMAE). After the antibody binds to ROR1 on cancer cells, the ADC can enter those cells, where the MMAE is released and can destroy the cancerous cells. In mouse models of human solid tumors, VLS-101 has caused highly significant tumor shrinkage.

This clinical trial is a Phase 2 study evaluating VLS-101 in patients with metastatic solid tumors that are likely to express ROR1. Accrual of subjects with any of the following tumor types is planned:

  • Previously treated triple-negative breast cancer (TNBC)
  • Previously treated estrogen receptor (ER)-positive, progesterone receptor (PR)-positive, or human epidermal growth factor receptor (HER2)-positive breast cancer
  • Previously treated non-squamous, non-small-cell lung cancer (NSCLC) Cohorts of subjects may be added as ROR1 expression information and relevant supporting data becomes available for other tumor types.

VLS-101 is administered intravenously in repeated 3-week cycles with a drug infusion on Day 1 of each cycle. For each patient, therapy can continue as long as the patient is tolerating the therapy and appears to have evidence of benefit.

During the study, blood testing is performed to assess for any VLS-101 effects on liver, kidney, and bone marrow (safety); evaluate how much VLS-101 and its breakdown products appear in the blood (pharmacokinetics); determine if VLS-101 is altering cancer cells or cancer-related proteins (pharmacodynamics); measure for antidrug antibodies to VLS-101 (immunogenicity); and examine tumors to understand whether the types of cancer cells will affect the study drug effects. Scans are performed periodically to assess for changes in tumor status.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of VLS-101 in Patients With Solid Tumors
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: VLS-101
Open label VLS-101 at 2.5 mg/kg given IV on Day 1 of repeated 21-day cycles.
Drug: VLS-101
Open-Label VLS-101

Primary Outcome Measures :
  1. Change from baseline in tumor dimensions [ Time Frame: Every 9-12 weeks up to 48 weeks and then every 12-18 weeks up to 96 weeks ]

Secondary Outcome Measures :
  1. Safety as assessed by the incidence of adverse events and laboratory abnormalities [ Time Frame: Weekly during the first 3 weeks and then every 3 weeks up to 96 weeks ]

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

  3. Serum concentrations of VLS-101-reactive antibodies [ Time Frame: Every 3 weeks up to 96 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Men or women of age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records.
  • Presence of metastatic disease that has progressed during or following previous treatment appropriate for the disease type.
  • Presence of radiographically measurable disease.
  • Availability of pretreatment tumor tissue.
  • Adequate hematological profile
  • Adequate hepatic profile
  • Adequate renal function
  • Negative testing or adequate therapy 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:

  • Peripheral neuropathy of Grade >1.
  • Presence of malignancy involving the central nervous system.
  • Presence of another major cancer.
  • Uncontrolled ongoing infection.
  • Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
  • Known diagnosis of liver cirrhosis.
  • Pregnancy or breastfeeding.
  • Major surgery within 4 weeks before the start of study therapy.
  • Prior treatment with a ROR-1-directed therapy.
  • Known tumor resistance or intolerance to a prior MMAE-containing drug.
  • 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): NCT04504916

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Contact: Anthony Viggiano 2062270171
Contact: Elizabeth Schmidt 2063005215

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United States, New Jersey
John Theurer Cancer Center, Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07602
Contact: Chelsea McCabe, CCRP    551-996-4725   
Principal Investigator: Martin Gutierrez, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Funda Meric-Bernstam, MD    713-794-1226   
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: NCT04504916    
Other Study ID Numbers: VLS-101-0003
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases