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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05360368

Enrollment

Registered

2022-05-04

Start date

2023-03-30

Completion date

2024-02-28

Last updated

2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

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.

Interventions

DRUGHLX07

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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;

Design outcomes

Primary

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

Measure	Time frame
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
Peak plasma concentration (Cmax) of HLX07	2 years
Objective response rate (ORR)	2 years
Disease control rate (DCR)	2 years
Duration of response (DOR)	2 years
Incidence of treatment-emergent anti-drug antibodies (ADA)	2 years
Time to peak (Tmax) of HLX07	2 years
Area under the concentration-time curve (AUC) of HLX07	2 years

Countries

China

Contacts

Primary ContactXuhui Hu, MD

Xuhui_Hu@henlius.com18618313742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026