Health TrialsbyHealthPanel

Safety and Efficacy of NK510 to Treat NSCLC

ConditionNSCLC
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBase Therapeutics (Shanghai) Co., Ltd.

About this trial

This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR/ROS1/ALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female.

For pleural perfusion group (Group D1/D2): Advanced NSCLC with malignant pleural effusion ≥500ml (confirmed by B-ultrasound or CT); patients with driver gene-positive and resistant to targeted therapy are acceptable.

At least one CT or MRI measurable lesion according to RECIST v1.1.

ECOG performance status 0-2.

Disqualifiers

Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.

Active, known or suspected autoimmune diseases (excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment [e.g., vitiligo, psoriasis, alopecia] or diseases not expected to recur without external triggers).

History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, grade III atrioventricular block); QTc interval >480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade ≥3 cardiovascular and cerebrovascular events within 6 months before enrollment; NYHA cardiac function class ≥II or left ventricular ejection fraction (LVEF) <50%; clinically uncontrolled hypertension.

Blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor treatment within 2 weeks before enrollment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • NK510

    Drug

    Intravenous infusion

  • Tislelizumab，atezolizumab or sugemalimab

    Drug

    Administer according to the instructions

  • NK510

    Drug

    intrapleural infusion

  • systemic therapy as selected by the investigator

    Drug

    Administer according to the instructions

Treatment groups

12 Participants
are divided into 5 treatment groups
Group A: Group A (low-dose group)Experimental treatment 2 interventions
Group B: Group B (medium-dose group)Experimental treatment 2 interventions
Group C: Group C (high-dose group)Experimental treatment 2 interventions
Group D: Group D1 (low-dose group)Experimental treatment 2 interventions
Group E: Group D2 (high-dose group)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity and incidence of adverse events

To evaluate DLT and the incidence of AEs associated with NK510 treatment

Time frame
6 weeks
2

Objective Response Rate

For intravenous groups: Proportion of subjects achieving CR and PR according to RECIST v1.1 after first NK510 administration; For pleural perfusion groups: Proportion of subjects achieving CR and PR according to WHO criteria after first NK510 intrapleural perfusion.

Time frame
6 weeks

Secondary outcomes

1

Progression-Free Survival

Time from first NK510 administration to disease progression or death.

Time frame
From the date of the first dose of NK510 until disease progression, death, or a maximum of 24 months after the first dose, whichever occurs first.
2

Puncture-Free Survival

Time from last treatment puncture to next puncture drainage (for pleural perfusion groups).

Time frame
From the date of the last treatment puncture to the date of the next puncture drainage, or up to a maximum of 24 months after the last treatment puncture, whichever occurs first.
3

Duration of Response

Time from achievement of response to disease progression.

Time frame
From the date of first documentation of objective response to disease progression, death, or a maximum of 24 months after the date of first response, whichever occurs first.
4

Disease Control Rate

Proportion of subjects achieving CR, PR or SD based on baseline tumor assessment.

Time frame
From baseline tumor assessment up to the earliest of disease progression，or a maximum of 24 months after baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Base Therapeutics (Shanghai) Co., Ltd.

Lead sponsor

Jinling Hospital, China

Collaborator

Source ClinicalTrials.gov
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