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Non Small Cell Lung Cancer (NSCLC)Phase 2NCT07283198

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

A Phase 2 study testing JSKN033 Injection in people with Non Small Cell Lung Cancer (NSCLC), run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer (NSCLC)
What is being tested?
JSKN033 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
10 Dec 2025to 30 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 1.
  • 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.
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  • 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.
  • Sufficient organ function.
  • Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use highly effective contraceptive measures from the time of signing the informed consent form until 24 weeks after the last dose.

Who cannot join

  • 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.
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  • 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).
  • Previous history of allogeneic bone marrow or organ transplantation.
  • Known allergy to any component of the study drug.
  • Pregnant and/or lactating women, or women planning to become pregnant during the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lin Wu, Doctor contact

+86 731 8976 2300

wulin-calf@vip.163.com

About this study

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.

Being tested
JSKN033 Injection
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN033 InjectionDrug

    JSKN033 is a fixed-dose combination consisting of JSKN003 (a HER2-targeted ADC) and envafolimab (a PD-L1 inhibitor)

Study groups in NCT07283198
Study groupRoleWhat they receive
Part 1 (Dose Selection) and Part 2 (Cohort Expansion)ExperimentalJSKN033 is administered at the predefined dose, once per treatment cycle.
Receives: Drug: JSKN033 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

  2. Objective response rate (ORR)

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

    Measured: Up to 1 year after the last participant receives the last dose

Secondary outcomes (15)

  1. Duration of response (DoR)

    Duration of response for responders (CR or PR) is defined as the time interval between the date of earliest qualifying response and the date of PD or death for any cause, whichever occurs earlier

    Measured: Up to 1 year after the last participant receives the last dose

  2. Disease control rate (DCR)

    DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)

    Measured: Up to 1 year after the last participant receives the last dose

  3. Clinical benefit rate (CBR)

    Clinical benefit rate (CR+PR+[stable disease (SD) ≥ 6 months]) is defined as those participants with best response as CR or PR or else SD with a duration of at least 6 months. SD for 6 months duration was defined as the time from the first dose to the first documentation of PD or to the last adequate response assessment prior to data cut-off date, whichever is earlier.

    Measured: Up to 1 year after the last participant receives the last dose

  4. Progression-free Survival (PFS)

    PFS is defined as the time from the date of first study dose to disease progression or death whichever occurs first. Subjects without event (no disease progression or alive at last visit) will be censored at the date of "last tumor assessment".

    Measured: Up to 1 year after the last participant receives the last dose

  5. Overall survival (OS)

    OS was defined as the time from the date of first dose until the date of death from any cause

    Measured: Up to 1 year after the last participant receives the last dose

  6. PK parameter: Cmax

    Maximum (Peak) Observed blood Concentration (Cmax)

    Measured: Post last dose up to Day 90

  7. PK parameter: Tmax

    Time of Maximum blood Concentration (Tmax)

    Measured: Post last dose up to Day 90

  8. PK parameter: AUC

    The blood PK parameters of JSKN033 and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.

    Measured: Post last dose up to Day 90

  9. PK parameter: Terminal Elimination Half-life (t1/2)

    Measured: Post last dose up to Day 90

  10. PK parameter: Volume of distribution (V)

    Measured: Post last dose up to Day 90

  11. PK parameter: trough concentration (Ctrough)

    Measured: Post last dose up to Day 90

  12. PK parameter: Clearance (CL)

    Measured: Post last dose up to Day 90

  13. PK parameter: Accumulation index (Rac)

    Measured: Post last dose up to Day 90

  14. PK parameter: Mean residence time (MRT)

    Measured: Post last dose up to Day 90

  15. Incidence of anti-drug antibodies (ADAs), antibody titers, and incidence of neutralizing antibodies

    Measured: Post last dose up to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start10 Dec 2025 (estimated)
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07283198
Sponsor's protocol ID
JSKN033-201
Status last verified
Dec 2025
First submitted
2 Dec 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JSKN033 Injection in people with Non Small Cell Lung Cancer (NSCLC), run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lin Wu, Doctor (+86 731 8976 2300, wulin-calf@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07283198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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