SKB500 Combinations in Patients With Small Cell Lung Cancer (NCT07296809) | Clinical Trial Compass
RecruitingPhase 2
SKB500 Combinations in Patients With Small Cell Lung Cancer
China80 participantsStarted 2026-01-30
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female participants between 18 and 75 years old.
✓. Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):
✓. 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.
Exclusion criteria
✕. The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.
✕. Has previously received medications with the same target or the same toxins.
✕. 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.
✕. Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose.
✕. History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions.
✕. 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.