Tests SKB500 combinations in people with small cell lung cancer
Tests SKB500 with other drugs in adults with small cell lung cancer.
Key facts
- Who runs it
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- SKB500 Combinations in Patients With Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 80 people, planned
- Started
- 30 Jan 2026
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 3 groups
- Treatments tested
- SKB500 Powder for Injection
- KL-A167 Injection
- Carboplatin Injection
- Etoposide Injection
- Record updated
- 8 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with extensive-stage small cell lung cancer, tested with SKB500 combinations.
- Age
- 18 to 75 years old.
- Sex
- Men and women can join.
- Disease stage
- Extensive-stage small cell lung cancer, confirmed by tissue or cell tests. At least one measurable tumor is needed.
- Earlier treatment
- Cohort 1: no more than 1 earlier systemic therapy in the extensive stage, or none. Cohorts 2 and 3: no earlier systemic treatment. Side effects of past cancer treatment must have settled to grade 1 or less.
- Biomarker or test result
- No specific marker is required. People must agree to give fresh or stored tumor tissue for biomarker tests.
Main reasons for not taking part
- Small cell cancer mixed with non-small cell cancer
- Earlier medicines with the same target or the same toxins
- Spinal cord compression or active brain or spinal metastases
- Serious lung disease, including interstitial lung disease or pneumonitis needing steroids
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- Male or female participants between 18 and 75 years old
- Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):; Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage; Cohort 2~3: participant has received no prior systemic treatment
- Agree to provide fresh or archival tumor tissue for biomarker analysis
- Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy >= 12 weeks
- Has adequate organ and bone marrow functions
- Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities
- Effective contraceptive methods should be used during the study and for 6 months after the end of treatment
- Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures
Who cannot take part
- Has previously received medications with the same target or the same toxins
- Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose
- Presence of uncontrolled concurrent diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Severe active peptic ulcer, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction, etc
- Clinical severe lung damage caused by concurrent lung disease
- History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions
- Serious or uncontrolled heart disease or clinical symptoms requiring treatment
- History of interstitial lung disease (ILD) /noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis
- Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion/pericardial effusion/ abdominal effusion
- Rapid disease deterioration in the screening process
- The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components
- Presence of spinal cord compression or clinically active central nervous system metastases
- Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels
- With peripheral neuropathy of grade ≥ 2
- Pregnant or lactating women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Yilong WuTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- 1. SKB500+KL-A167Treatment being tested
Participants will receive KL-A167 followed by SKB500
Treatment: SKB500 Powder for Injection and KL-A167 Injection
- 2. SKB500 +KL-A167+CarboplatinTreatment being tested
Participants will receive KL-A167 followed by SKB500 with Carboplatin
Treatment: SKB500 Powder for Injection, KL-A167 Injection, and Carboplatin Injection
- 3. SKB500+KL-A167+Carboplatin+EtoposideTreatment being tested
Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide
Treatment: SKB500 Powder for Injection, KL-A167 Injection, Carboplatin Injection, and Etoposide Injection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer
- Plain-language title
- Tests SKB500 combinations in people with small cell lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07296809, who can take part
- Record updated
- 8 May 2026