Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Estrogen Receptor Positive Breast Cancer
  • Human Epidermal Growth Factor 2 Positive Carcinoma of Breast
  • Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
  • Progesterone Receptor-positive Breast Cancer
  • Triple Negative Breast Cancer (TNBC)
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 reappe...

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.

Tracking Information

NCT #
NCT04504916
Collaborators
Not Provided
Investigators
Study Director: Langdon L Miller, MD VelosBio Inc.