Evaluation of JSKN016 Combination Therapy in Subjects with NSCLC
NCT ID: NCT06868732
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
288 participants
INTERVENTIONAL
2025-03-12
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort -1A-a
Receive JSKN016 in combination with carboplatin, administered intravenously at the dosage specified in the protocol.
JSKN016
Administered intravenously according to protocol.
Carboplatin
AUC 4, Q3W, administered intravenously according to protocol.
Cohort -1A-b
Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
JSKN016
Administered intravenously according to protocol.
Furmonertinib Mesylate
160mg, qd, administered according to protocol.
Cohort -1B-c
Receive JSKN016 in combination with ivonescimab, administered intravenously at the dosage specified in the protocol.
JSKN016
Administered intravenously according to protocol.
Ivonescimab
20mg/kg, Q3W, administered intravenously according to protocol.
Cohort -1B-d
Receive JSKN016 in combination with ivonescimab and carboplatin, administered intravenously at the dosage specified in the protocol.
JSKN016
Administered intravenously according to protocol.
Carboplatin
AUC 4, Q3W, administered intravenously according to protocol.
Ivonescimab
20mg/kg, Q3W, administered intravenously according to protocol.
Cohort -2
Receive JSKN016 in combination with docetaxel, administered intravenously at the dosage specified in the protocol.
JSKN016
Administered intravenously according to protocol.
Docetaxel
60mg/m\^2, Q3W, administered intravenously according to protocol.
Cohort -3-f
Receive JSKN016 in combination with tislelizumab, administered intravenously at the dosage specified in the protocol.
JSKN016
Administered intravenously according to protocol.
Tislelizumab
200mg, Q3W, administered intravenously according to protocol.
Cohort -3-g
Receive JSKN016 in combination with tislelizumab and carboplatin, administered intravenously at the dosage specified in the protocol.
JSKN016
Administered intravenously according to protocol.
Carboplatin
AUC 4, Q3W, administered intravenously according to protocol.
Tislelizumab
200mg, Q3W, administered intravenously according to protocol.
Cohort -4
Receive JSKN016 in combination with pembrolizumab, administered intravenously at the dosage specified in the protocol.
JSKN016
Administered intravenously according to protocol.
Pembrolizumab
200mg, Q3W, administered intravenously according to protocol.
Interventions
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JSKN016
Administered intravenously according to protocol.
Carboplatin
AUC 4, Q3W, administered intravenously according to protocol.
Furmonertinib Mesylate
160mg, qd, administered according to protocol.
Ivonescimab
20mg/kg, Q3W, administered intravenously according to protocol.
Docetaxel
60mg/m\^2, Q3W, administered intravenously according to protocol.
Tislelizumab
200mg, Q3W, administered intravenously according to protocol.
Pembrolizumab
200mg, Q3W, administered intravenously according to protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years old, ≤ 75 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.
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu Alphamab Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Li Zhang
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Central Contacts
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Other Identifiers
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JSKN016-102
Identifier Type: -
Identifier Source: org_study_id
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