HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors

A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors

This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.

Inclusion Criteria:

• Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
• Aged ≥ 18 years, ≤ 75 years;
• Patients must have histologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
• Measurable disease according to RECIST Version 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• Expected survival 12 weeks;
• Adequate organ function;
• For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose;

Exclusion Criteria:

• Prior anti-EGFR (including EGFR ADC) monoclonal antibody therapy;
• A history of other malignancies within two years, except for cured Localized tumor;
• Participants with any prior allogeneic solid organ or bone marrow transplantations;
• Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable);
• Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• Active clinical severe infection;