Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

March 25, 2026 updated by: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort -1A-a
Receive JSKN016 in combination with carboplatin, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Carboplatin
AUC 5, Q3W, administered intravenously according to protocol.
Other Names:
  • Carboplatin Injection
Experimental: Cohort -1A-b
Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Furmonertinib Mesylate
160mg（cohort1A-b）or 80mg（cohort 5）, qd, administered according to protocol.
Other Names:
  • Furmonertinib Mesylate Tablets
Experimental: Cohort -2
Receive JSKN016 in combination with docetaxel, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Docetaxel
60mg/m^2, Q3W, administered intravenously according to protocol.
Other Names:
  • Docetaxel injection
Experimental: Cohort -4
Receive JSKN016 in combination with pembrolizumab, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Pembrolizumab
200mg, Q3W, administered intravenously according to protocol.
Other Names:
  • Pembrolizumab Injection
Experimental: Cohort -1B
Receive JSKN016 in combination with ivonescimab, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Ivonescimab
20mg/kg, Q3W, administered intravenously according to protocol.
Other Names:
  • Ivonescimab Injection
Experimental: Cohort -3A
Receive JSKN016 in combination with tislelizumab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Tislelizumab
200mg, Q3W, administered intravenously according to protocol.
Other Names:
  • Tislelizumab Injection
Drug: Carboplatin
AUC 5, Q3W, administered intravenously according to protocol.
Other Names:
  • Carboplatin Injection
Experimental: Cohort -3B
Receive JSKN016 in combination with ivonescimab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Ivonescimab
20mg/kg, Q3W, administered intravenously according to protocol.
Other Names:
  • Ivonescimab Injection
Drug: Carboplatin
AUC 5, Q3W, administered intravenously according to protocol.
Other Names:
  • Carboplatin Injection
Experimental: Cohort -5
Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Furmonertinib Mesylate
160mg（cohort1A-b）or 80mg（cohort 5）, qd, administered according to protocol.
Other Names:
  • Furmonertinib Mesylate Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety reflected by AE
Time Frame: Up to 24months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Up to 24months
ORR assessed by the investigator per RECIST v1.1
Time Frame: Up to 24months
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Up to 24months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOR assessed by the investigator per RECIST v1.1
Time Frame: Up to 24months
Duration of response (DoR) assessed according to RECIST v1.1.
Up to 24months
DCR assessed by the investigator per RECIST v1.1
Time Frame: Up to 24months
Disease control rate (DCR) assessed according to RECIST v1.1.
Up to 24months
TTR assessed by the investigator per RECIST v1.1
Time Frame: Up to 24months
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Up to 24months
PFS assessed by investigator per RECIST v1.1
Time Frame: Up to 24months
Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
Up to 24months
OS
Time Frame: Up to 24months
Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.
Up to 24months
ADA
Time Frame: Up to 24months
Number of subjects with detectable anti-drug antibodies (ADA).
Up to 24months
Peak Plasma Concentration (Cmax)
Time Frame: Up to 24months
The Peak Plasma Concentration (Cmax) of the antibody-drug conjugate (ADC), total antibody and free payload.
Up to 24months
Trough Plasma Concentration (Cmin)
Time Frame: Up to 24 months
The Trough Plasma Concentration (Cmin) of the antibody-drug conjugate (ADC), total antibody and free payload.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Investigators

  • Principal Investigator: Li Zhang, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 9, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSKN016-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe