A Study of SKB518 in Patients With Advanced Solid Tumors

Launched by SICHUAN KELUN PHARMACEUTICAL RESEARCH INSTITUTE CO., LTD. · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SKB518 for adults with advanced solid tumors, which are types of cancer that have spread and are no longer responding to standard treatments. The trial aims to understand how safe this new treatment is, how well it works, and how the body processes it. It is an early-stage study, which means it’s one of the first times this treatment is being tested in people. The trial is not yet recruiting participants, but when it begins, it will welcome adults who are at least 18 years old and have a specific type of advanced cancer that has either worsened after treatment or for which no effective treatment is available.

To be eligible for the trial, participants will need to provide a sample of their tumor tissue for testing and have at least one measurable tumor. They should also be in good overall health, have a life expectancy of at least three months, and have recovered from any previous cancer treatments. However, people with certain health issues, such as uncontrolled infections or recent major surgeries, may not qualify. If someone joins this trial, they can expect regular check-ups and monitoring while receiving the study treatment. This trial is an important step in finding new options for patients with limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject must be at least 18 years of age at the time of signing the informed consent;
• • 2. Histological or cytological diagnosis of solid tumor that is advanced/metastatic solid tumor by pathology report and have progressed on, have been intolerant to, or have been ineligible for standard of care treatments.
• • 3. Subjects able to provide tumor blocks or 8\~10 slides \[fresh paraffin-embedded tumor tissue or archived paraffin-embedded tumor tissue (maximum time limit is not more than 2 years)\] before the first dose of study intervention for biomarkers testing.
• • 4. At least one measurable lesion can be accurately measured per RECIST v1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• • 5. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• • 6. Life expectancy of at least 3 months as assessed by the investigators.
• • 7. Subjects with adequate organ and bone marrow function confirmed by laboratory results within 7 days prior to the first dose.
• • 8. Has recovered from all toxicities from previous therapy with the exception of stable, chronic (\>3 months) toxicities not considered a safety risk (e.g. alopecia, vitiligo), after consultation with the Sponsor.
• • 9. Subjects of childbearing potential (male or female) must use effective medical contraception during the study until 6 months after the last dose.
• • 10. Subjects must be able to provide documented voluntary informed consent.
• Exclusion Criteria:
• • 1. Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
• • 2. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
• • 3. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases.
• • 4. Has serious and/or uncontrolled concomitant diseases.
• • 5. Has known active tuberculosis.
• • 6. Has known human immunodeficiency virus (HIV) infection that is not well controlled.
• • 7. Has any active viral hepatitis, hepatitis B or hepatitis C.
• • 8. Has had major surgery within 28 days prior to the first dose.
• • 9. Has known allergy or hypersensitivity to SKB518, or the excipients of SKB518.
• • 10. Has a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis that required steroids.
• • 11. Clinically serious lung injuries caused by lung diseases.
• • 12. History of documented severe dry eye syndrome.
• • 13. Has a history of allogeneic tissue/solid organ transplant.
• • 14. Has known uncontrollable effusion.
• • 15. Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
• • 16. Has received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or has received BCRP inhibitors within 2 weeks prior to the first dose.
• • 17. Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks; or who received any small molecular tyrosine kinase inhibitor, antitumor hormonal therapy, system immune-stimulator, or therapy with traditional Chinese medicines approved for antitumor treatment, etc. within 2 weeks before the first dose.
• • 18. Has an active infection requiring systemic therapy.
• • 19. Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of \>10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
• • 20. Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of fist dose.
• • 21. Before the first dose, the subject's condition deteriorates rapidly.
• • 22. Has a known psychiatric or substance abuse disorders.
• • 23. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.