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

Henlius Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Solid Tumor

Treatments: Drug: HLX07

Study type: Interventional

Funder types: Industry

Identifiers

NCT05360368

HLX07-103

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

HLX07

Experimental group

Description:

This study uses the "3+3" design to investigate the safety and determine the MTD of HLX07. Four dose levels of 800 mg, 1200 mg, 1500 mg and 1800 mg are planned for dose finding. Enrollment will continue until a maximum of 24 patients are enrolled.

Treatment:

Drug: HLX07