eligibility_summary
Inclusion: ≥18, ECOG 0–1, measurable advanced solid tumor, adequate organs, required tumor tissue (fresh biopsies in some), contraception. A/C: selected tumors, B: molecularly defined tumors (B1 may forgo approved tx, B2 after/unsuited to standard), D: mTNBC or metastatic HR+/HER2− BC. Exclusion: pregnancy, hypersensitivity, prohibited meds, MDS/AML, malabsorption, recent major surgery/therapy, transplant, immunodeficiency or >10 mg steroids, active 2nd cancer/CNS mets, cardiac disease, HBV/HCV/HIV, pneumonitis/ILD, live vaccines <4 wks. Combo cohorts also exclude IBD, recent obstruction/perforation, prior topo‑I drugs/ADCs, severe mAb/IVIG reactions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: GS-0201 (oral, first-in-human investigational small-molecule) tested alone and with sacituzumab govitecan (SG, IV antibody–drug conjugate, IMMU-132/Trodelvy). Mechanisms: SG binds the TROP-2 surface antigen on tumor cells and delivers SN-38 (topoisomerase I inhibitor), inducing DNA damage and cytotoxicity. The precise molecular target/mechanism of GS-0201 is not disclosed in the listing, it is evaluated in tumors with selected molecular lesions. Cells/pathways targeted: TROP-2–expressing tumor cells and the DNA replication/repair pathway via topo I (with SG), GS-0201 targets a pathway defined by tumor genomic alterations (details not specified). Indications include advanced solid tumors, with expansion in mTNBC and HR+/HER2- breast cancer.