Search / Trial NCT06223256

A Study of NBL-028 in Patients With Advanced Solid Tumors

Launched by NOVAROCK BIOTHERAPEUTICS, LTD · Jan 15, 2024

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Trial Information

Current as of December 30, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NBL-028 for patients with advanced solid tumors that express a specific protein called Claudin 6 (CLDN6). The trial is for adults who have already tried standard treatments that did not work or were not suitable for them. It is divided into two parts: the first part will determine the safest and most effective dose of NBL-028, and the second part will enroll additional patients to further test this dose.

To be eligible for this trial, participants must be at least 18 years old, have a diagnosed advanced solid tumor that shows positive CLDN6 expression, and have at least one measurable tumor that can be evaluated. Patients need to provide tumor tissue samples or agree to a biopsy for testing. They must also be in good overall health, with a life expectancy of at least three months. Participants can expect close monitoring during the study, and they will need to follow safety guidelines, including using effective birth control if they are of childbearing age. This trial is currently recruiting participants, and it aims to help find new treatment options for those with limited choices.

Gender

ALL

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.

Trial Officials

Ruihua Xu, Ph.D

Principal Investigator

Sun Yat-Sen University (SYSU) Cancer Center

About Novarock Biotherapeutics, Ltd

Novarock Biotherapeutics, Ltd. is a pioneering biotechnology company dedicated to the development and commercialization of innovative therapies for the treatment of serious and complex diseases. With a focus on harnessing advanced biotherapeutic technologies, Novarock is committed to addressing unmet medical needs through its robust pipeline of novel drug candidates. The company leverages a team of experienced scientists and industry professionals to drive its research and development efforts, ensuring that its products are backed by rigorous scientific evidence and clinical validation. Novarock Biotherapeutics aims to transform patient care by delivering safe and effective therapeutic solutions that improve health outcomes and enhance quality of life.

Locations

Shijiazhuang, Hebei, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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