A Study of VLS-101 in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04504916|
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : December 24, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Open label VLS-101 at 2.5 mg/kg given IV on Day 1 of repeated 21-day cycles.
- 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 ]Response
- 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 ]Safety
- Plasma VLS-101 drug concentrations [ Time Frame: Weekly during the first 3 weeks and then every 3 weeks up to 96 weeks ]Pharmacokinetics
- Serum concentrations of VLS-101-reactive antibodies [ Time Frame: Every 3 weeks up to 96 weeks ]Immunogenicity
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 ClinicalTrials.gov identifier (NCT number): NCT04504916
|Contact: Anthony Viggianofirstname.lastname@example.org|
|Contact: Elizabeth Schmidtemail@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Study Director:||Langdon L Miller, MD||VelosBio Inc.|