First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies (NCT04763083) | Clinical Trial Compass
UnknownPhase 1
First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies
United Kingdom90 participantsStarted 2021-05-14
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Personally signed informed consent document.
* Male or female, age ≥18 years.
* Relapsed or refractory ROR1+ malignancies
* ECOG performance status ≤2.
* Adequate organ function.
* Bilirubin ≤1.5 x ULN (unless Gilbert's syndrome).
* AST and ALT ≤2.5 x ULN (if no hepatic CLL or MCL), or AST and ALT ≤5 x ULN (if hepatic CLL or MCL).
* APTT and PT ≤1.5 x ULN.
* ANC ≥0.5 x 10\^9 /L (without growth factors) and platelets ≥ 30 x 10\^9 /L (without transfusion).
* Serum creatinine ≤2 x ULN.
* Estimated creatinine clearance ≥30 mL/min.
* In females of childbearing potential, a negative serum pregnancy test.
* For both males and females, willingness to use adequate contraception.
* Willingness and ability to comply with study procedures.
Exclusion Criteria:
* Richter's transformation.
* CNS or leptomeningeal active disease.
* High tumour bulk as defined in the protocol.
* Allogeneic or autologous organ transplant within prior 6 months.
* Uncontrolled autoimmune haemolytic anaemia or idiopathic thrombocytopenic purpura within 8 weeks of screening.
* Clinically significant neurological disease.
* Clinically significant cardiovascular disease or ECG abnormalities.
* Severe chronic lung disease.
* Positive test at Screening for HIV, hepatitis B or hepatitis C infection.
* Any other concurrent cancer or cancer treatments.
* Uncontrolled ongoing infection
* Recent major surgery
* Concurrent participation in another clinical trial, or experimental therapy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of treatment-emergent adverse events (TEAEs)
Timeframe: Up to 10 months
2
Number of serious adverse events (SAEs)
Timeframe: Up to 10 months
3
Number of adverse events of special interest (AESI)