SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT07697586
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • SKB264+SKB118 — DRUG
    Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.

Study Details

This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.

Key Dates

First listed
Jul 13, 2026
Start date
Aug 7, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
206 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SKB264 in combination with SKB118
    SKB264 at 4 mg/kg combined with SKB118 at 3 mg/kg, 10 mg/kg, 20 mg/kg, or other dose levels

Primary Outcome Measure

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: From enrollment to the end of treatment at 24 months ]

Central Contacts

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