Actively Recruiting
A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.
Led by NovaRock Biotherapeutics, Ltd · Updated on 2024-03-26
200
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and tolerability of NBL-020 injection in subjects with advanced malignant tumors, and determine the dose limiting toxicity (DLT), maximum tolerable dose (MTD) (if any), recommended phase II dose (RP2D), and dosing regimen of NBL-020.
CONDITIONS
Official Title
A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older and voluntarily sign the informed consent form.
- Confirmed malignant tumors by histology or cytology; solid tumors for dose escalation, with possible inclusion of skin T-cell lymphoma in dose expansion.
- Willingness to provide tumor tissue samples suitable for biomarker testing, preferably fresh biopsy or samples within 2 years.
- Previous cancer treatment must have failed, be intolerable, or not available; participants must have recovered with adverse events at level 0-1 (except certain non-safety risks).
- At least one measurable lesion meeting RECIST 1.1 criteria that has not been recently radiated or has progressed after radiotherapy.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1.
- Expected survival time of at least 3 months.
- Good organ function as defined by specified blood counts, kidney and liver tests, and coagulation function.
- Agreement to use effective contraception from consent until 6 months after last dose; women of childbearing age must have a negative pregnancy test within 7 days before first dose.
You will not qualify if you...
- History of severe allergies to monoclonal antibodies.
- Active symptomatic brain metastases requiring treatment; asymptomatic and stable brain metastases allowed.
- Active autoimmune diseases except well-controlled type I diabetes, hypothyroidism on hormone therapy, or certain skin diseases without systemic treatment.
- History of primary immunodeficiency or organ/hematopoietic stem cell transplantation.
- Chronic hepatitis B or C not meeting inclusion criteria, or HIV positive.
- Previous treatment toxicities not resolved to Grade 1 or less (except certain non-safety risks).
- Serious cardiovascular diseases including recent myocardial infarction, unstable angina, heart failure NYHA Grade III or above, prolonged QT/QTc, low ejection fraction, or poorly controlled hypertension.
- Uncontrollable serous cavity effusions requiring frequent intervention.
- Severe infections needing systemic treatment within 14 days before first dose (except treated viral hepatitis).
- Recent anti-tumor treatments or clinical trial participation within 4 weeks or 5 half-lives.
- History or current interstitial lung disease requiring steroids.
- Use of systemic corticosteroids or immunosuppressive therapy within 14 days before first dose (with some exceptions).
- History of severe immune-related adverse events after immunotherapy.
- Prior targeted TNFR2 treatment.
- Major surgery within 4 weeks before first dose or planned during the study.
- Other malignancies within 3 years except some local curable cancers.
- Pregnant or breastfeeding women.
- Concurrent participation in other interventional clinical studies.
- History of neurological or mental disorders including epilepsy or dementia.
- Any condition judged by researchers as unsuitable for participation due to safety risks or compliance concerns.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wu Yilong
Guanzhou, Guangdong, China
Actively Recruiting
Research Team
Y
Yilong Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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