eligibility_summary
Inclusion: Adults 18–75 with histologically confirmed advanced/metastatic solid tumors after failure/intolerance/ineligibility of standard therapy, measurable disease (RECIST 1.1), ECOG 0–1, ≥12‑week survival, adequate organ function, negative pregnancy test if fertile female. Exclusion: prior anti‑EGFR (incl. ADC) therapy, other malignancy <2 yrs (except cured localized), prior allogeneic transplant, symptomatic brain/meningeal mets unless treated >3 mo, no progression x4 wks, symptoms stable, uncontrolled effusions, severe active infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05360368 tests HLX07, a recombinant humanized anti‑EGFR monoclonal antibody (IV q3w, 800–1800 mg) in a Phase 1, open‑label 3+3 dose‑escalation study for advanced/metastatic solid tumors post‑standard therapy failure. Mechanism: HLX07 binds the extracellular domain of EGFR (HER1/ErbB1), blocking ligand (EGF/TGF‑α) binding and receptor activation, thereby inhibiting downstream signaling pathways (RAS‑RAF‑MEK‑ERK and PI3K‑AKT) to reduce tumor cell proliferation and survival, as an IgG mAb, it may also trigger ADCC against EGFR‑expressing cells. Targets: EGFR‑positive tumor cells, the EGFR signaling axis, and engagement of immune effector cells (e.g., NK cells via Fcγ receptors). Primary aims: safety, tolerability, PK, preliminary antitumor activity.