SKB500 Combinations in Patients With Small Cell Lung Cancer
NCT ID: NCT07296809
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-12-20
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1. SKB500+KL-A167
Participants will receive KL-A167 followed by SKB500
SKB500 Powder for Injection
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
KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
2. SKB500 +KL-A167+Carboplatin
Participants will receive KL-A167 followed by SKB500 with Carboplatin
SKB500 Powder for Injection
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
KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
Carboplatin Injection
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)
3. SKB500+KL-A167+Carboplatin+Etoposide
Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide
SKB500 Powder for Injection
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
KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
Carboplatin Injection
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
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SKB500 Powder for Injection
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
KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
Carboplatin Injection
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
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. Agree to provide fresh or archival tumor tissue for biomarker analysis.
4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy \>= 12 weeks.
7. Has adequate organ and bone marrow functions.
8. Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
9. Effective contraceptive methods should be used during the study and for 6 months after the end of treatment.
10. Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures.
Exclusion Criteria
2. Has previously received medications with the same target or the same toxins.
3. Presence of spinal cord compression or clinically active central nervous system metastases.
4. Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.
5. Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose.
6. With peripheral neuropathy of grade ≥ 2.
7. History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions.
8. 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.
9. Serious or uncontrolled heart disease or clinical symptoms requiring treatment.
10. History of interstitial lung disease (ILD) /noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis.
11. Clinical severe lung damage caused by concurrent lung disease.
12. Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion/pericardial effusion/ abdominal effusion.
13. Pregnant or lactating women.
14. Rapid disease deterioration in the screening process.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yilong Wu
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yilong Wu
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SKB500-II-02
Identifier Type: -
Identifier Source: org_study_id