Testing NVG-111 for certain blood cancers and solid tumors
An Open-label, Phase 1, First in Human Study Investigating the Safety, Tolerability, Pharmacokinetics and Efficacy of NVG-111 in Subjects With Relapsed/Refractory ROR1+ Malignancies
This study is testing a new treatment called NVG-111 to see if it can help people with certain blood cancers and solid tumors by boosting their immune system to fight the cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NovalGen Ltd. Industry-sponsored |
| Locations | 3 sites (London and 2 other locations) |
| Trial ID | NCT04763083 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates NVG-111, a bispecific antibody designed to target ROR1 on cancer cells and engage the immune system to attack these cells. It is a Phase 1 study focusing on patients with relapsed or refractory ROR1+ malignancies, including various types of lymphomas and solid tumors. Participants will receive the drug through continuous intravenous infusion over three cycles, with safety and efficacy monitored throughout the treatment. The study aims to determine the recommended dose for future phases and assess the drug's pharmacokinetics and pharmacodynamics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory ROR1+ malignancies and adequate organ function.
Not a fit: Patients with Richter's transformation or active CNS disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat ROR1+ malignancies.
How similar studies have performed: While this is a first-in-human study, similar bispecific T cell engagers have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 within 5 half-lives of Screening * Pregnant or currently breastfeeding. * Any other medical condition that in the opinion of the investigator contraindicates participation in the study.
Where this trial is running
London and 2 other locations
- University College London Hospital — London, United Kingdom (Recruiting)
- Royal Marsden Hospital — London, United Kingdom (Recruiting)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Parag Jasani, MBBS, FRCP, FRCPath — Royal Free London NHS Foundation Trust and University College London Hospitals
- Study coordinator: Amit C Nathwani, MBChB, FRCP, FRCPath, PhD
- Email: a.nathwani@novalgen.co.uk
- Phone: 0044 207 139 8639
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.