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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: HLX07

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200000
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HLX07; 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; 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; Other Names: Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Duration of response (DOR)	2 years
Objective response rate (ORR)	2 years
Incidence of treatment-emergent anti-drug antibodies (ADA)	2 years
Disease control rate (DCR)	2 years
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

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 30, 2023
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): February 28, 2024

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (ACTUAL): May 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HLX07-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No