Actively Recruiting
A Study of NBL-028 in Patients With Advanced Solid Tumors
Led by NovaRock Biotherapeutics, Ltd · Updated on 2024-03-18
270
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design including accelerated titration to determine the maximum tolerated dose (MTD) of NBL-028. Dose expansion - Additional patients (no more than 200) will be enrolled at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Sponsor may elect to enroll specific tumor types into four cohorts.
CONDITIONS
Official Title
A Study of NBL-028 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who have understood the study and signed informed consent
- Diagnosed with advanced solid tumors expressing CLDN6, either failing, intolerant to, or without standard treatments
- Able to provide preserved tumor tissue or agree to tumor biopsy for central testing
- Have at least one measurable target lesion according to RECIST 1.1
- ECOG performance status of 0 or 1 at screening
- Life expectancy of 3 months or more
- Adequate organ function within 7 days before first dose (specific blood counts and liver/kidney function levels)
- Negative pregnancy test for women of childbearing potential within 7 days before first dose
- Agreement to use effective contraception from consent signing to 3 months after last dose, with women non-lactating and men refraining from sperm donation
You will not qualify if you...
- Previous treatment targeting CLDN6 or CD137
- Uncontrolled central nervous system cancer or metastasis
- High bleeding risk due to tumor invading important arteries
- Uncontrolled fluid accumulation requiring repeated drainage
- Unresolved adverse events from prior anti-tumor treatments above Grade 1
- Immune-related adverse events of Grade 3 or higher from prior immunotherapy
- Presence of other malignant tumors requiring treatment
- Recent anti-tumor treatments or investigational treatments within 4 weeks or 5 half-lives
- Live viral vaccine within 4 weeks before first dose
- Immunosuppressive medication within 2 weeks before first dose
- Active serious infections requiring treatment within 2 weeks before first dose
- Radiation or localized palliative treatment within 2 weeks before first dose
- Major surgery within 4 weeks before first dose or planned during the study
- History of serious cardiovascular disease
- Active or history of autoimmune diseases
- History of immunodeficiency or organ transplantation
- Active hepatitis B or C, syphilis, or active tuberculosis infection
- Allergy to humanized monoclonal antibody products
- Women who are pregnant or breastfeeding
- Fertile patients unwilling to use effective contraception during and 6 months after the trial
- Other conditions that may affect safety or compliance including psychiatric or severe diseases
AI-Screening
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Trial Site Locations
Total: 1 location
1
No.896 East Zhongshan Road, Shijiazhuang, Hebei Province, China.
Shijiazhuang, Hebei, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
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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