eligibility_summary
Adults ≥18 with metastatic/advanced solid tumor, measurable disease, ECOG 0–1, adequate organ function. Prior SOC tried/ineffective or declined. Must comply and allow tumor biopsy (archival ok). Contraception required, not pregnant/breastfeeding. Controlled HIV/HBV/HCV ok. Part B: NSCLC, SCLC, or gastric cancer. Exclude: recent therapy/surgery, ≥G2 neuropathy, transplant, unresolved >G1 AEs, QTcF>470, hypersensitivity, untreated CNS mets, significant cardiac/comorbidity, prior TROP2 ADC (Phase 2), prohibited meds.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests OBI-992, an anti-TROP2 antibody-drug conjugate (ADC) given as monotherapy. Composition: a TROP2-targeting monoclonal antibody linked via a cleavable peptide to exatecan, a camptothecin-class topoisomerase I inhibitor. Mechanism of action: the antibody binds TROP2 on tumor cells, is internalized, the linker is cleaved, and exatecan is released to inhibit topoisomerase I, inducing DNA damage, S-phase arrest, and apoptosis. Target cells/pathways: TROP2-expressing epithelial tumors (advanced solid tumors), with expansion in NSCLC, SCLC, and gastric cancer, key pathways include TROP2-mediated endocytosis and DNA replication/repair via topoisomerase I. Phase 1/2 dose escalation (Q3W, 1–10 mg/kg) followed by dose-optimized expansions.