Clinical trial NCT06775483: Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study
Official title: Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Non-small Cell Lung Cancer
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.

Detailed description: This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.

Eligibility criteria: Inclusion Criteria:

1. Voluntarily participate and sign the informed consent form.
2. Age ≥ 18 years old, male or female.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
4. Expected survival ≥ 3 months.
5. 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, and meets one of the following conditions: EGFR sensitive mutations, and failed treatment with EGFR-TKI; Driver gene negative, treated with PD-1/L1 inhibitors and a platinum-containing chemotherapy and treatment failure; Positive driver gene, failure of corresponding standard therapy;
6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
7. Recently archived or fresh tumor tissue samples are available.
8. Have good organ function.
9. Have no current birth plans and agree to contraception during the trial.

Exclusion Criteria:

1. Presence of any small cell carcinoma component in histopathology.
2. 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.
3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.
4. 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.
5. Adequate washout of previous therapy before the first dose.
6. Gastrointestinal abnormalities with obvious clinical manifestations.
7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
9. 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.
10. Previous treatment with docetaxel.
11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.
12. Previous history of allogeneic bone marrow or organ transplantation.
13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.
14. Pregnant and/or lactating females.
15. 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.

Primary outcomes:
measure: ORR assessed by the investigator per RECIST v1.1
timeFrame: Up to 24months
measure: Safety reflected by AE
timeFrame: Up to 24months
Secondary outcomes:
measure: DOR assessed by the investigator per RECIST v1.1
timeFrame: Up to 24months
measure: DCR assessed by the investigator per RECIST v1.1
timeFrame: Up to 24months
measure: TTR assessed by the investigator per RECIST v1.1
timeFrame: Up to 24months
measure: PFS assessed by investigator per RECIST v1.1
timeFrame: Up to 24months
measure: OS
timeFrame: Up to 24months
measure: Cmax of JSKN016
timeFrame: Up to 24months
measure: AUC of JSKN016
timeFrame: Up to 24months
measure: Tmax of JSKN016
timeFrame: Up to 24months
measure: ADA
timeFrame: Up to 24months
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Li zhang
role: PRINCIPAL_INVESTIGATOR
References: