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

NCT05360368 | Unknown Phase 1

• 1 other identifier: HLX07-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

Study Arms (1)

HLX07

EXPERIMENTAL

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

Interventions

HLX07 DRUG

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

Also known as: Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection

HLX07

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Fudan University shanghai cancer center

Shanghai, 200000, China

Location

MeSH Terms

Interventions

HLX07

Central Study Contacts

Xuhui Hu, MD

CONTACT

18618313742; Xuhui_Hu@henlius.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 4, 2022
• Study Start: March 30, 2023
• Primary Completion: December 30, 2023
• Study Completion: February 28, 2024
• Last Updated: May 5, 2022

Record last verified: 2022-04

Locations

CN (1)