Testing NBL-028 in patients with advanced solid tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NBL-028 in Patients With Advanced Solid Tumors

This study is testing a new treatment called NBL-028 for patients with advanced solid tumors that have run out of other treatment options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NovaRock Biotherapeutics, Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06223256 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, interventional study evaluating the safety and efficacy of NBL-028 in patients with advanced solid tumors that express Claudin 6 (CLDN6). The trial consists of two stages: a dose-escalation phase to determine the maximum tolerated dose using a Bayesian optimal interval design, followed by a dose-expansion phase enrolling additional patients at the recommended dose. Participants must have tumors that have either failed standard treatments or for which no standard treatments are available. The study aims to provide a new treatment option for patients with limited alternatives.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors expressing CLDN6 who have exhausted standard treatment options.

Not a fit: Patients with solid tumors that do not express CLDN6 or those who have not failed standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors that currently have no effective standard care.

How similar studies have performed: While this approach is novel in targeting CLDN6, similar studies targeting specific biomarkers in advanced solid tumors have shown promise in the past.

Eligibility criteria

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\^9/L; Platelet count (PLT) ≥100×10\^9/L;. Hemoglobin (HGB) ≥90 g/L; Serum creatinine ≤ 1.5 × ULN or Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥50 mL/min; Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN when patients with Gilbert's disease); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver involvement is known).
8. Serum pregnancy test for women of childbearing potential (WOCBP) is negative within 7 days prior to the first dose of the investigational drug. The patient and his/her spouse must agree to use adequate contraception from signing of informed consent form (ICF) to 3 months after the last dose, during which women should be non-lactating and men should refrain from donating sperm.

Exclusion Criteria:

1. Previously received CLDN6-targeted or CD137-targeted treatment.
2. Known uncontrolled central nervous system (CNS) cancer including CNS metastasis, meningeal metastasis, or spinal cord compression.
3. Patients with high risk of bleeding due to tumor invasion of important arteries.
4. Has uncontrolled serous cavity effusion (such as pleural effusion, abdominal effusion, or pericardial effusion, etc) requiring repeated drainage.
5. Has adverse events due to previous anti-tumor treatments that have not yet recovered to ≤Grade 1 according to NCI-CTCAE v5.0;
6. Developed immune-related adverse events (irAE) of grade ≥3 (CTCAE 5.0) with prior immunotherapy
7. Known to exist any other malignant tumor requiring intervention.
8. Have received anti-tumor treatments (such as chemotherapy, targeted therapy, biological therapy, etc.) or any other investigational drugs or treatments within 4 weeks or 5 half-lives, whichever is shorter.
9. Have received a live viral vaccine within 4 weeks before the first dose of study drug.
10. Have received immunosuppressive medications within 2 weeks prior to the first dose of study drug.
11. Have active or serious bacterial, fungal, or viral infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose of study drug.
12. Have received radiation therapy or other localized palliative treatment within 2 weeks before the first dose of study drug.
13. Have undergone major surgery within 4 weeks before the first dose of study drug, or scheduled to have major surgery during the study.
14. Have a history of serious cardiovascular disease.
15. Have active or history of autoimmune diseases.
16. A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
17. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis.
18. Hypersensitive to humanized monoclonal antibody products.
19. Women during lactation or pregnancy.
20. Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration.
21. Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.

Where this trial is running

Shijiazhuang, Hebei

• No.896 East Zhongshan Road, Shijiazhuang, Hebei Province, China. — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Principal investigator: Ruihua Xu, Ph.D — Sun Yat-Sen University (SYSU) Cancer Center
• Study coordinator: Clinical Trials Information Group officer

Conditions Advanced Solid Tumor