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Recruiting Phase 1

Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

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About this study

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.

Condition
Advanced Non-small Cell Lung Cancer
Tested
JSKN016, Carboplatin, Furmonertinib Mesylate, Ivonescimab, Docetaxel, Tislelizumab, Pembrolizumab
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Advanced Non-small Cell Lung Cancer
  • Voluntarily participate and sign the informed consent form.
  • Age ≥ 18 years old, ≤ 75 years old, male or female.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • Expected survival ≥ 3 months.
  • Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy.
  • At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
  • Recently archived or fresh tumor tissue samples are available.
  • Have good organ function.
  • Have no current birth plans and agree to contraception during the trial.

Exclusion 15

  • Presence of any small cell carcinoma component in histopathology.
  • Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate/cervical/breast cancer in situ.
  • Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.
  • During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.
  • Adequate washout of previous therapy before the first dose.
  • Gastrointestinal abnormalities with obvious clinical manifestations.
  • Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
  • Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
  • Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3.
  • Previous treatment with docetaxel.
  • Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.
  • Previous history of allogeneic bone marrow or organ transplantation.
  • Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.
  • Pregnant and/or lactating females.
  • Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.

Where

1 site, 1 recruiting

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.