Clinical trial · Interventional
First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukaemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NVG-111 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: Haematological malignancies
- interventionNames
- Drug: NVG-111
- type
- EXPERIMENTAL
- label
- Group B: Solid tumours
- interventionNames
- Drug: NVG-111
Primary outcomes (8)
- measure
- Number of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 10 months
- description
- Safety parameter assessed by: type, frequency, severity and treatment-relatedness of AEs following commencement of dosing
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available