A Study of NBL-028 in Patients With Advanced Solid Tumors
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 b
| Condition(s) | Advanced Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Patients ≥18 years old, should have fully understood the study and voluntarily signed an informed consent form. 2. Patients with pathologically diagnosed advanced solid tumors with positive expression of CLDN6. Stage I: Patients have failed or cannot tolerate standard of care, or without standard treatment; Stage Ⅱ: Previously treated advanced solid tumors. 3. Be able to provide previously well-preserved tumor tissue sections, or agree to undergo tumor tissue biopsy for central laboratory biomarker testing. 4. At least one measurable target lesion according to RECIST 1.1. 5. ECOG performance status of 0 or 1 at screening. 6. Life expectancy ≥3 months. 7. Adequate organ function within 7 days prior to the first dose defined as: Absolute neutrophil count (ANC) ≥1.5×10\ |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | NovaRock Biotherapeutics, Ltd |
| Locations | Shijiazhuang, Hebei, China |
| Start date | 2024-03-08 |
| NCT ID | NCT06223256 |
| Official listing | https://clinicaltrials.gov/study/NCT06223256 |