eligibility_summary
Eligible adults (≥18, Part 1 ≤75) with histologically/cytologically confirmed unresectable/metastatic or extensive-stage SCLC, ECOG 0–1, life expectancy ≥12 weeks, adequate organ function, and informed consent. Exclude: other interventional trials, unresolved ≥Grade 2 toxicities, allergy to IBI3009/excipients, recent/planned major surgery or unhealed wounds, pregnant/positive test/lactating, or investigator-deemed unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06613009 (Phase 1) in unresectable/metastatic or extensive-stage small cell lung cancer. Intervention: IBI3009, a monoclonal antibody–camptothecin derivative conjugate (antibody–drug conjugate, ADC) given by injection. Mechanism of action: The antibody binds a tumor-associated surface antigen (not specified in the registry), is internalized, and releases a camptothecin-derived payload that inhibits topoisomerase I, causing DNA damage, replication stress, and tumor cell death, potential bystander effect on neighboring tumor cells. Targets (cells/pathways): Antigen-expressing SCLC tumor cells, DNA replication/repair pathways via topoisomerase I inhibition and downstream DNA damage response/apoptosis. Primary aim: assess safety/tolerability and define MTD/RDE.