SKB500 Combinations in Patients With Small Cell Lung Cancer

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT07296809
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • SKB500 Powder for Injection — DRUG
    SKB500 will be administered as an intravenous (IV) infusion, every 3 weeks on Day 1 of each 21-day cycle and the dose will be determined based on the efficacy and safety data from the SKB500-I-01 study.
  • KL-A167 Injection — DRUG
    KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
  • Carboplatin Injection — DRUG
    Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle（AUC 5, Cycles 1-4)
  • Etoposide Injection — DRUG
    Etoposide will be administered as an intravenous (IV) infusion every 3 weeks on Day 1, 2, and 3 of each 21-day cycle (100 mg/m\^2, Cycles 1-4).

Study Details

The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.

Key Dates

First listed
Dec 22, 2025
Start date
Jan 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: 1. SKB500+KL-A167
    Participants will receive KL-A167 followed by SKB500
  • Experimental: 2. SKB500 +KL-A167+Carboplatin
    Participants will receive KL-A167 followed by SKB500 with Carboplatin
  • Experimental: 3. SKB500+KL-A167+Carboplatin+Etoposide
    Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide

Primary Outcome Measure

Incidence and severity of adverse events (AEs) [ Time Frame: up to 24 months ]

Central Contacts

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