Status:
UNKNOWN
First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies
Lead Sponsor:
NovalGen Ltd.
Conditions:
Chronic Lymphocytic Leukaemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 canc...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04763083
Start Date
May 14 2021
End Date
December 1 2025
Last Update
July 7 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University College London Hospital
London, United Kingdom, W1T 7HA
2
Royal Marsden Hospital
London, United Kingdom
3
The Christie NHS Foundation Trust
Manchester, United Kingdom