eligibility_summary
Eligibility: 18–75. Phase Ia: adv/met NSCLC with EGFR‑activating mutations, post/intolerant/no SoC. Phase Ib: A) NSCLC EGFR exon20ins post/intolerant to platinum, B) other adv solid tumors post/intolerant to SoC. Require tumor tissue, RECIST target, ECOG 0–1, life >12 wks, avoid pregnancy. Exclude: prior exon20ins tx (A), recent anticancer tx/RT/surgery, effusions, ≥G2 tox, other cancers, active/untreated CNS mets, organ/CV dz, bleeding/thrombosis/infection, ILD, neuro/psych dz, allergy, unsafe cond.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: HS-20117 (PM1080), a fully human IgG1-like bispecific antibody targeting EGFR and MET, administered IV as monotherapy in a Phase I, single-arm study. Mechanism: dual binding to EGFR and MET to block ligand binding and receptor activation and disrupt EGFR–MET crosstalk, thereby inhibiting downstream MAPK/ERK and PI3K/AKT signaling that drives tumor cell proliferation/survival, its IgG1-like Fc may also mediate immune effector functions (e.g., ADCC). Cells/pathways targeted: tumor cells with EGFR-activating mutations, including exon 20 insertions, and tumors relying on EGFR and/or MET signaling or MET-mediated resistance. Indication focus: advanced/metastatic NSCLC, with exploration in other solid tumors.