Search / Trial NCT06226766

JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors

Launched by JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD · Jan 18, 2024

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Trial Information

Current as of December 31, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JSKN033 for patients with advanced solid tumors that cannot be surgically removed or have spread to other parts of the body. The trial aims to find out if JSKN033 is safe and effective for patients whose tumors have a certain protein called HER2. If you or a loved one have a type of cancer that meets these criteria and have tried other treatments without success, this study might be an option.

To participate, patients need to be at least 18 years old and willing to follow the study procedures. They should have a specific type of advanced cancer with HER2 expression and be in relatively good health, meaning they can perform daily activities without much assistance. Participants will receive the study drug and will be closely monitored for any side effects and how well the treatment works. It's important to know that certain medical conditions, such as untreated brain metastases or severe allergies to related medications, may prevent someone from joining the study. Overall, this trial is an opportunity to explore a potentially new treatment for challenging cancers.

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ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 1. Be willing and able to provide written informed consent form (ICF) for the trial.
  • • 2. Male or female, 18 years of age or older; willing and able to complete all required procedures of study.
  • • 3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, and life expectancy ≥ 12 weeks.
  • • 4. Must have a pathologically documented advanced unresectable or metastatic solid malignant tumor (gastrointestinal tumor for dose expansion phase) with HER2 expression (IHC ≥1+) that is refractory to or intolerable with standard treatment, or for which no effective standard treatment is available. HER2 mutation in patients with NSCLC is also regarded as HER2 expression.
  • • 5. Baseline measurable disease according to RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • • 6. Adequate organ function assessed within 7 days prior to first trial treatment \[had not received blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or other relevant medical support within 14 days before the administration of the investigational product\].
  • • 7. Have adequate treatment washout period before first dose.
  • • 8. Have LVEF ≥50% by either echo cardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days prior to first dose.
  • • 9. Female or male patients of childbearing potential should be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 180 days after completion of study treatment. Female of childbearing potential should have a negative pregnancy test within 7 days prior to first trial treatment (childbearing potential is defined as premenopausal females without documented tubal ligation or hysterectomy, or postmenopausal females within 1 year).
  • Exclusion Criteria:
  • • 1. Patients with untreated active brain metastases or meningeal or spinal cord metastases are excluded. If the subject has received treatment for brain metastases and the metastases are stable (as evidenced by brain imaging within 28 days prior to study treatment showing stable disease, no new lesions, and no new neurological symptoms, and no requirement for steroids for at least 14 days prior to study treatment), they may be eligible for enrollment.
  • • 2. Concurrent malignancy within 5 years prior to first dose other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer, thyroid cancer not requiring treatment, ductal carcinoma in situ of the breast, or \< T1 urothelial carcinoma.
  • • 3. Prior treatment with an antibody-drug conjugate (ADC) which consists of a topoisomerase I inhibitor derivative.
  • • 4. History of uncontrolled concurrent illness.
  • • 5. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by image at screening.
  • • 6. Previous severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms will be excluded, or must have resolved and based on investigator assessment, there are no sequela that would place participant at a higher risk of receiving investigational treatment.
  • • 7. Patients with ascites, pleural effusion, pericardial effusion which cannot be controlled by appropriate interventions.
  • • 8. Have unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, grade 2 hypoparathyroidism) related to prior anticancer therapy and stable anemia not yet resolved to grade ≤ 1 (NCI-CTCAEV5.0).
  • • 9. Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. A brief course of corticosteroids for the prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
  • • 10. History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or excipients in JSKN033 drug formulation.
  • • 11. Prior history of anti-HER2 therapy induced angioedema, or severe hypotension and Severe allergic reactions to other antibody drugs or topoisomerase I inhibitors.
  • • 12. Other conditions that, in the investigators' opinion, would make patients inappropriate to participate in this study, such as a history of mental illness, alcoholism or drug abuse.

Trial Officials

Charlotte Lemech

Principal Investigator

Scientia Clinical Research

About Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Jiangsu Alphamab Biopharmaceuticals Co., Ltd. is a leading biotechnology company based in China, specializing in the discovery, development, and commercialization of innovative biopharmaceuticals. With a focus on monoclonal antibodies and other targeted therapies, the company aims to address unmet medical needs across various therapeutic areas, including oncology and autoimmune diseases. Leveraging advanced technology platforms and a robust pipeline, Jiangsu Alphamab is committed to enhancing patient outcomes through cutting-edge research and development, while adhering to the highest standards of quality and regulatory compliance in clinical trials.

Locations

Randwick, New South Wales, Australia

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0