Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study ID
NCT06868732
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • JSKN016 — DRUG
    Administered intravenously according to protocol.
  • Carboplatin — DRUG
    AUC 5, Q3W, administered intravenously according to protocol.
  • Furmonertinib Mesylate — DRUG
    160mg（cohort1A-b）or 80mg（cohort 5）, qd, administered according to protocol.
  • Ivonescimab — DRUG
    20mg/kg, Q3W, administered intravenously according to protocol.
  • Docetaxel — DRUG
    60mg/m\^2, Q3W, administered intravenously according to protocol.
  • Tislelizumab — DRUG
    200mg, Q3W, administered intravenously according to protocol.
  • Pembrolizumab — DRUG
    200mg, Q3W, administered intravenously according to protocol.

Study Details

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.

Key Dates

Start date
Apr 2, 2025
Status verified
Mar 2025
Primary completion
Jun 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
288 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort -1A-a
    Receive JSKN016 in combination with carboplatin, administered intravenously at the dosage specified in the protocol.
  • Experimental: Cohort -1A-b
    Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
  • Experimental: Cohort -1B
    Receive JSKN016 in combination with ivonescimab, administered intravenously at the dosage specified in the protocol.
  • Experimental: Cohort -2
    Receive JSKN016 in combination with docetaxel, administered intravenously at the dosage specified in the protocol.
  • Experimental: Cohort -3A
    Receive JSKN016 in combination with tislelizumab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
  • Experimental: Cohort -3B
    Receive JSKN016 in combination with ivonescimab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
  • Experimental: Cohort -4
    Receive JSKN016 in combination with pembrolizumab, administered intravenously at the dosage specified in the protocol.
  • Experimental: Cohort -5
    Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.

Primary Outcome Measure

ORR assessed by the investigator per RECIST v1.1 [ Time Frame: Up to 24months ]

Central Contacts

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