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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: HLX07


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX07<br>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. | Drug: HLX07<br>* A Recombinant Humanized Anti-EGFR Monoclonal Antibody, HLX07 will be administered as a single intravenous (IV) infusion on Day 1 in each 3-week cycle<br>* Other names: Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of Treatment-Related Adverse Events |  | 2 years | 
| The proportion of patients experiencing dose limiting toxicity (DLT) events |  | from first dose to the end of Cycle 1 (each cycle is 21 days) | 
| The maximum tolerated dose (MTD) |  | from first dose to the end of Cycle 1 (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of HLX07 |  | 2 years | 
| Time to peak (Tmax) of HLX07 |  | 2 years | 
| Area under the concentration-time curve (AUC) of HLX07 |  | 2 years | 
| Elimination half-life (t1/2) of HLX07 |  | 2 years | 
| Clearance (CL) of HLX07 |  | 2 years | 
| Volume of distribution (Vz) of HLX07 |  | 2 years | 
| Accumulation Index (Rac) of HLX07 |  | 2 years | 
| Incidence of treatment-emergent anti-drug antibodies (ADA) |  | 2 years | 
| Objective response rate (ORR) |  | 2 years | 
| Disease control rate (DCR) |  | 2 years | 
| Duration of response (DOR) |  | 2 years |