A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer

Jiangsu Alphamab Biopharmaceuticals Co., Ltd0 sites160 target enrollmentDecember 10, 2025

InterventionsJSKN033 Injection

Overview

Phase: Phase 2
Intervention: JSKN033 Injection
Conditions: Not specified
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Enrollment: 160
Primary Endpoint: Number and Severity of Treatment-emergent Adverse Events (TEAEs)
Status: Not yet recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is an open-label, multicenter, Phase II clinical study designed to evaluate the safety and efficacy of JSKN033 in the treatment of patients with advanced NSCLC. The study is divided into two phases: Part 1 (Dose Selection) and Part 2 (Cohort Expansion). Enrolled subjects are patients with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative treatment. Part 1 (Dose Selection): It consists of two dose groups, with a maximum of 20 subjects enrolled in each group. Part 2 (Cohort Expansion): It consists of two cohorts, with a maximum of 60 subjects enrolled in each cohort.

Registry

clinicaltrials.gov

Start Date

December 10, 2025

End Date

August 30, 2027

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects can understand the informed consent form,voluntarily participate in the study, and sign the informed consent form.
•Subjects are≥18 years old on the day of signing the informed consent form, regardless of gender.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
•Expected survival time ≥3 months.
•Histologically or cytologically confirmed locally advanced or metastatic NSCLC (per AJCC 8th Edition Lung Cancer TNM Staging) that is not eligible for curative surgery and/or curative radiotherapy.
•NSCLC confirmed to be no other known driver gene alterations for which first- line targeted therapy has been approved.
•For Part 1(Dose Selection): Enrolled subjects are those with advanced unresectable or metastatic NSCLC who have failed or are intolerant to standard previous treatments, and have HER2 mutation or HER2 expression in tumor tissue.
•For Part 2 (Cohort Expansion): Enrolled subjects are those with locally advanced or metastatic NSCLC who have not received prior systemic anti-tumor treatment for their advanced disease.
•Per RECIST 1.1 criteria,subjects have at least one extracranial measurable lesion at baseline.
•Subjects must provide tumor tissue samples.

Exclusion Criteria

•Presence of any small cell carcinoma component in the histological pathology.
•History of other malignant tumors within 5 years prior to the first dose administration.
•History of brainstem, meningeal, or spinal cord metastases/compression, or carcinomatous meningitis; presence of active brain metastases.
•Imaging during the screening phase shows tumor invasion, compression, or location in surrounding vital organs.
•Sufficient washout period from previous treatments prior to the first dose.
•Presence of the following lung diseases or medical history leading to severe respiratory impairment.
•Presence of risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia.
•Presence of cardiovascular and cerebrovascular diseases or risk factors.
•Presence of uncontrolled infections.
•Toxicity from previous anti-tumor treatment has not recovered to grade≤1 (per CTCAE v5.0).

Arms & Interventions

Part 1 (Dose Selection) and Part 2 (Cohort Expansion)

JSKN033 is administered at the predefined dose, once per treatment cycle.

Intervention: JSKN033 Injection

Outcomes

Primary Outcomes

Number and Severity of Treatment-emergent Adverse Events (TEAEs)

Time Frame: Baseline up to 30 days after the last dose of study drug, up to 1 year

The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.

Objective response rate (ORR)

Time Frame: Up to 1 year after the last participant receives the last dose

ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)

Secondary Outcomes

PK parameter: trough concentration (Ctrough)(Post last dose up to Day 90)
PK parameter: Clearance (CL)(Post last dose up to Day 90)
PK parameter: Accumulation index (Rac)(Post last dose up to Day 90)
PK parameter: Mean residence time (MRT)(Post last dose up to Day 90)
Incidence of anti-drug antibodies (ADAs), antibody titers, and incidence of neutralizing antibodies(Post last dose up to Day 90)
Overall survival (OS)(Up to 1 year after the last participant receives the last dose)
PK parameter: Cmax(Post last dose up to Day 90)
Duration of response (DoR)(Up to 1 year after the last participant receives the last dose)
Disease control rate (DCR)(Up to 1 year after the last participant receives the last dose)
Clinical benefit rate (CBR)(Up to 1 year after the last participant receives the last dose)
PK parameter: Tmax(Post last dose up to Day 90)
Progression-free Survival (PFS)(Up to 1 year after the last participant receives the last dose)
PK parameter: AUC(Post last dose up to Day 90)
PK parameter: Terminal Elimination Half-life (t1/2)(Post last dose up to Day 90)
PK parameter: Volume of distribution (V)(Post last dose up to Day 90)