Health TrialsbyHealthPanel

A Study of SKB518 in Patients With Lung Cancer

ConditionLung Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.

Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.

At least one measurable tumor lesion per RECIST v1.1.

Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.

Disqualifiers

Symptomatic or uncontrolled cardiovascular disease

History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;

Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.

Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SKB518

    Drug

    SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

  • Tislelizumab

    Drug

    Tislelizumab is administered every 3 weeks(200 mg, Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

  • Carboplatin

    Drug

    Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles

Treatment groups

192 Participants
are divided into 3 treatment groups
Group A: 2L+ SCLC or non-Squamous NSCLCExperimental treatment 1 intervention
Group B: 2L SCLCExperimental treatment 2 interventions
Group C: 1L ES-SCLCExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

AE

Incidence and severity of Adverse Events (AEs)

Time frame
Up to 24 months
2

ORR in specific arms

Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1

Time frame
Up to 24 months
3

PFS in specific arm

Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1

Time frame
Up to 24 months

Secondary outcomes

1

PFS in specific arms

Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

Time frame
Up to 24 months
2

DOR in specific arms

Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.

Time frame
Up to 24 months
3

OS

Time from start of treatment to death due to any reason.

Time frame
Up to 24 months
4

Pharmacokinetics

Maximum and minimum drug concentrations (Cmax and Cmin) of SKB518-ADC and SKB518-TAb (antibody-drug conjugate and total antibody forms of SKB518) in Serum; Cmax and Cmin of SKB518-Free Payload in Plasma

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

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

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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