Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of NBL-020 Injection in Adults With Advanced Malignant Tumors
Led by NovaRock Biotherapeutics, Ltd · Updated on 2024-03-26
200
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of NBL-020 injection in adults with advanced malignant tumors. This Phase 1 study aims to find the dose limiting toxicity, maximum tolerable dose, recommended phase II dose, and the best dosing schedule for NBL-020. The study includes patients with various solid tumors and may include skin T-cell lymphoma in the dose expansion phase. The study has two parts: dose escalation and dose expansion. The dose escalation starts with 0.1 mg/kg of NBL-020 given intravenously once every 3 weeks, with possible increases up to 30 mg/kg. The Safety Management Committee may adjust doses or dosing intervals based on safety and effectiveness data. In the dose expansion phase, the dose will be selected based on results from the escalation phase, with possible multiple doses evaluated. Participants will undergo regular assessments including monitoring for adverse events up to 30 days after the last dose, with follow-up lasting up to about 2 years. Blood tests will measure drug levels and immune response, and tumor tissue samples will be collected for biomarker testing. Researchers will also evaluate tumor response, disease control, progression-free and overall survival. Participants are monitored closely for safety throughout the study period.
CONDITIONS
Brief Title
A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and able to sign informed consent
- Diagnosed with malignant tumors confirmed by histology or cytology; solid tumors for dose escalation and possibly skin T-cell lymphoma for dose expansion
- Willing to provide tumor tissue samples suitable for biomarker testing (preferably fresh biopsy or samples within 2 years)
- Recovered from prior treatment toxicity to Grade 0-1 (except non-safety risk toxicities like alopecia)
- At least one measurable lesion per RECIST 1.1 at baseline
- ECOG performance status score of 0 or 1
- Expected survival time of 3 months or more
- Good organ function with specified blood counts and liver/kidney function within normal or allowed limits
- Agree to effective contraception during the study and for 6 months after last dose; women must have negative pregnancy test before first dose
You will not qualify if you...
- History of severe allergy to monoclonal antibodies
- Active pia mater lesions or uncontrolled brain metastases needing treatment; stable brain metastases allowed
- Active autoimmune diseases except well-controlled type I diabetes, hypothyroidism on hormone replacement, or non-systemic skin diseases
- History of primary immunodeficiency or organ/hematopoietic stem cell transplantation
- Chronic hepatitis B or C with active infection or HIV positive
- Previous treatment toxicities not recovered to Grade 1 or less
- Serious cardiovascular diseases including recent myocardial infarction, heart failure NYHA grade III or above, prolonged QT/QTc, or poor blood pressure control
- Uncontrollable serous cavity effusions requiring frequent drainage
- Severe infections needing systemic treatment within 14 days
- Recent anti-tumor or clinical research treatments within 4 weeks
- History or current pneumonia/interstitial lung disease requiring steroids
- Recent systemic corticosteroid or immunosuppressive therapy within 14 days
- History of severe immune-related adverse events from immunotherapy
- Prior targeted TNFR2 treatment
- Recent major surgery within 4 weeks or planned during study
- Other active malignancies within 3 years except certain treated skin or in situ cancers
- Pregnant or lactating women
- Participation in another intervention clinical trial concurrently
- History of neurological or mental disorders like epilepsy or dementia
- Other conditions deemed unsuitable by researchers including severe medical issues or safety risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration depending on dose escalation and expansion phases
Participants receive NBL-020 injections intravenously once every 3 weeks or at adjusted intervals depending on dose escalation results. The treatment dose starts at 0.1 mg/kg and may increase up to 30 mg/kg depending on safety and tolerance.
Visits every 2 to 4 weeks for dosing and assessments
Duration - Up to approximately 2 years
Participants are monitored for safety and anti-tumor activity for up to approximately 2 years after the last dose.
Periodic visits during the follow-up period
Trial Site Locations
Total: 1 location
1
Wu Yilong
Guanzhou, Guangdong, China
Actively Recruiting
Research Team
Y
Yilong Wu
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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