Evaluation of JSKN016 Combination Therapy in Subjects with NSCLC

Alphamab

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Non-small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Furmonertinib Mesylate; Drug: Tislelizumab; Drug: Docetaxel; Drug: Pembrolizumab; Drug: Ivonescimab; Drug: JSKN016

Study type: Interventional

Funder types: Industry

Identifiers

NCT06868732

JSKN016-102

Details and patient eligibility

About

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.

Full description

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. The primary objective of the study is to assess the efficacy and safety of JSKN016 in combination therapy in selected subjects with advanced non-small cell lung cancer.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily participate and sign the informed consent form.
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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 8 patient groups

Cohort -1A-a

Experimental group

Description:

Receive JSKN016 in combination with carboplatin, administered intravenously at the dosage specified in the protocol.

Treatment:

Drug: JSKN016

Drug: Carboplatin

Cohort -1A-b

Experimental group

Description:

Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.

Treatment:

Drug: JSKN016

Drug: Furmonertinib Mesylate

Cohort -1B-c

Experimental group

Description:

Receive JSKN016 in combination with ivonescimab, administered intravenously at the dosage specified in the protocol.

Treatment:

Drug: JSKN016

Drug: Ivonescimab

Cohort -1B-d

Experimental group

Description:

Receive JSKN016 in combination with ivonescimab and carboplatin, administered intravenously at the dosage specified in the protocol.

Treatment:

Drug: JSKN016

Drug: Ivonescimab

Drug: Carboplatin

Cohort -2

Experimental group

Description:

Receive JSKN016 in combination with docetaxel, administered intravenously at the dosage specified in the protocol.

Treatment:

Drug: JSKN016

Drug: Docetaxel

Cohort -3-f

Experimental group

Description:

Receive JSKN016 in combination with tislelizumab, administered intravenously at the dosage specified in the protocol.

Treatment:

Drug: JSKN016

Drug: Tislelizumab

Cohort -3-g

Experimental group

Description:

Receive JSKN016 in combination with tislelizumab and carboplatin, administered intravenously at the dosage specified in the protocol.

Treatment:

Drug: JSKN016

Drug: Tislelizumab

Drug: Carboplatin

Cohort -4

Experimental group

Description:

Receive JSKN016 in combination with pembrolizumab, administered intravenously at the dosage specified in the protocol.

Treatment:

Drug: JSKN016

Drug: Pembrolizumab