A Phase 1 interventional study of NVG-111 in Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma and Mantle Cell Lymphoma, sponsored by NovalGen Ltd.. Status unknown at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by NovalGen Ltd. · Phase 1, Interventional, and Treatment
NVG-111 is a bispecific antibody drug, having two "arms", one arm attaches to a substance on cancer cells called ROR1, the other arm attaches to the body's immune cells directing them to kill the cancer cells. This is the first clinical trial of the drug NVG-111, and will include patients with certain types of cancer including chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) mantle cell lymphoma (MCL), follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL) in Group A. Subjects with solid tumours, focusing initially on stage IV non-small cell lung cancer (NSCLC) or malignant melanoma.
Receptor tyrosine kinase-like Orphan Receptor 1 (ROR1) is a protein which is expressed at high levels on many types of cancers but is absent or expressed at low levels in normal adult organs. NVG-111 is a bispecific antibody T cell engager, comprising tandem single chain variable fragments (scFv), one arm binding to ROR1 on cancer cells, the other to cell surface CD3 on lymphocytes. Dual binding of NVG-111 causes MHC-independent immunological synapse formation, releasing perforins, granzyme B and cytokines, resulting in targeted killing of the cancer cells.
This is a Phase 1 first in human study to assess the safety, pharmacokinetics and efficacy of NVG-111 in patients with subjects with relapsed/refractory ROR1+ malignancies.
A range of doses will be studied in sequential cohorts to understand safety, pharmacokinetics and pharmacodynamics of the drug and establish the recommended phase 2 dose (RP2D). At each dose level, patients will receive 3 cycles of NVG-111 by continuous intravenous infusion, each cycle consists of 21 days treatment. Additional cycles may be given depending on the response seen.
All patients will have a safety follow up visit 4 weeks after completion of treatment with NVG-111, and will then enter long term follow up for up to two years to evaluate the duration of efficacy.
129 studies on the registry are indexed under Leukemia, B-Cell; 46 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 112 interventional studies indexed under Leukemia, B-Cell.
Browse Leukemia, B-Cell studies →This is the only study on the registry with NovalGen Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate organ function.
Exclusion Criteria:
Drug: NVG-111
Drug: NVG-111
Open label, continuous iv infusion, escalating doses of NVG-111 for minimum 3 cycles
Number of treatment-emergent adverse events (TEAEs)
Safety parameter assessed by: type, frequency, severity and treatment-relatedness of AEs following commencement of dosing
Time frame: Up to 10 months
Number of serious adverse events (SAEs)
Safety parameter defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or is medically significant/important
Time frame: Up to 10 months
Number of adverse events of special interest (AESI)
Safety parameter: specific protocol-defined AEs of Grade \>=3
Time frame: Up to 10 months
Number of dose limiting toxicities (DLTs)
Safety parameter assessed by protocol-defined adverse events
Time frame: Up to 28 days
Laboratory safety abnormalities
Safety parameter assessed by absolute values and change from baseline in laboratory safety assessments
Time frame: Up to 10 months
Vital sign abnormalities
Safety parameter assessed by absolute values and change from baseline in vital signs
Time frame: Up to 10 months
ECG abnormalities
Safety parameter assessed by absolute value and change from baseline in ECG intervals including QTcF
Time frame: Up to 10 months
Changes from baseline in ECOG
Safety parameter assessed by change from baseline in ECOG performance status
Time frame: Up to 10 months
Plan to share: Undecided — The company is developing an IPD sharing plan which will be completed and posted prior to primary completion date of the study
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.