eligibility_summary
Adults (≥18) with FOLR1+ high-grade serous ovarian/fallopian tube/primary peritoneal cancer, ECOG 0–1, relapsed platinum-resistant after 1–3 regimens, prior bevacizumab if SOC or contraindicated, ≥1 RECIST v1.1 lesion, adequate organs. Exclude: low-grade/clear cell/mucinous/endometrioid/sarcomatous/mixed, prior FOLR1-ADC or tubulin-ADC, primary platinum-refractory, severe antibody allergy, major ocular/pulmonary/cardiac/CNS disease or uncontrolled illness, solid organ transplant, other therapy trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
REFRaME-O1 (NCT05870748) tests luveltamab tazevibulin (STRO-002) vs investigator’s-choice chemotherapy in relapsed, platinum-resistant epithelial ovarian cancer expressing FOLR1. Luveltamab tazevibulin is an antibody-drug conjugate (human IgG1 anti-FOLR1, SP8166) with a cleavable hemiasterlin payload (SC209), after FOLR1 binding and internalization, the payload inhibits tubulin polymerization, causing mitotic arrest and cell death. Targets/pathways: FOLR1-positive tumor cells, microtubules. Comparator drugs/mechanisms: gemcitabine (nucleoside analog, inhibits ribonucleotide reductase/DNA synthesis), paclitaxel (taxane, stabilizes microtubules), pegylated liposomal doxorubicin (anthracycline, DNA intercalation/topo II, ROS), topotecan (topoisomerase I inhibitor). Pegfilgrastim (pegylated G-CSF) may be used to boost neutrophils and reduce infection risk.