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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05360368
• Other study ID #: HLX07-103
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 30, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2022
• Source: Shanghai Henlius Biotech
• Contact: Xuhui Hu, MD
• Phone: 18618313742
• Email: Xuhui_Hu[@]henlius.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: February 28, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	Fudan University shanghai cancer center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Treatment-Related Adverse Events		2 years
Primary	The proportion of patients experiencing dose limiting toxicity (DLT) events		from first dose to the end of Cycle 1 (each cycle is 21 days)
Primary	The maximum tolerated dose (MTD)		from first dose to the end of Cycle 1 (each cycle is 21 days)
Secondary	Peak plasma concentration (Cmax) of HLX07		2 years
Secondary	Time to peak (Tmax) of HLX07		2 years
Secondary	Area under the concentration-time curve (AUC) of HLX07		2 years
Secondary	Elimination half-life (t1/2) of HLX07		2 years
Secondary	Clearance (CL) of HLX07		2 years
Secondary	Volume of distribution (Vz) of HLX07		2 years
Secondary	Accumulation Index (Rac) of HLX07		2 years
Secondary	Incidence of treatment-emergent anti-drug antibodies (ADA)		2 years
Secondary	Objective response rate (ORR)		2 years
Secondary	Disease control rate (DCR)		2 years
Secondary	Duration of response (DOR)		2 years