A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

Sponsor
Klus Pharma Inc.
Study ID
NCT05816252
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SKB264 — DRUG
    intravenous (IV) infusion (Q2W or Q3W)
  • Pembrolizumab — DRUG
    intravenous (IV) infusion (400mg, Q6W)
  • Carboplatin — DRUG
    intravenous (IV) infusion (AUC5, Q3W)
  • Osimertinib — DRUG
    80mg, QD

Study Details

The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.

Key Dates

Start date
Apr 19, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
356 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%
    SKB264 (Dose Level 1) + Pembrolizumab
  • Experimental: Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
    SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin
  • Experimental: Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
    SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin
  • Experimental: Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy
    SKB264 (Dose Level 1') + Carboplatin
  • Experimental: Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy
    SKB264 (Dose Level 1'') + Carboplatin
  • Experimental: Cohort 7 1L NSCLC with EGFR mutation
    SKB264 (Dose Level 1) + Osimertinib
  • Experimental: Cohort 7-1 1L NSCLC with EGFR mutation
    SKB264 (Dose Level 2) + Osimertinib
  • Experimental: Cohort 9 2/3L NSCLC EGFR/ALK negative
    SKB264 (Dose Level 1)

Primary Outcome Measure

Safety and tolerability [ Time Frame: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months ]

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