First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies

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 (ifhepatic 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 (withouttransfusion).
• 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 purpurawithin 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 5half-lives of Screening
• Pregnant or currently breastfeeding.
• Any other medical condition that in the opinion of the investigator contraindicatesparticipation in the study.