CClinicalTrials.gg
Sign In
Status unknownNCT05360368Updated May 5, 2022

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

A Phase 1 interventional study of HLX07 in Solid Tumor, sponsored by Shanghai Henlius Biotech. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Shanghai Henlius Biotech · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumor

Browse trials for

03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 24 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shanghai Henlius Biotech is the lead sponsor of 127 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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

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

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

06

What researchers measure

Primary outcomes

  1. The Incidence of Treatment-Related Adverse Events

    Time frame: 2 years

  2. The proportion of patients experiencing dose limiting toxicity (DLT) events

    Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)

  3. The maximum tolerated dose (MTD)

    Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)

Secondary outcomes

  1. Peak plasma concentration (Cmax) of HLX07

    Time frame: 2 years

  2. Time to peak (Tmax) of HLX07

    Time frame: 2 years

  3. Area under the concentration-time curve (AUC) of HLX07

    Time frame: 2 years

  4. Elimination half-life (t1/2) of HLX07

    Time frame: 2 years

  5. Clearance (CL) of HLX07

    Time frame: 2 years

  6. Volume of distribution (Vz) of HLX07

    Time frame: 2 years

  7. Accumulation Index (Rac) of HLX07

    Time frame: 2 years

  8. Incidence of treatment-emergent anti-drug antibodies (ADA)

    Time frame: 2 years

  9. Objective response rate (ORR)

    Time frame: 2 years

  10. Disease control rate (DCR)

    Time frame: 2 years

  11. Duration of response (DOR)

    Time frame: 2 years

07

Study locations

1 site
  • Fudan University shanghai cancer center
    Shanghai, 200000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05360368
Lead sponsor
Shanghai Henlius Biotech
Responsible party
Sponsor
First posted
May 4, 2022
Start date
Mar 30, 2023 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Feb 28, 2024 (estimated)
Last update
May 5, 2022

Study contacts

Xuhui Hu, MD
Contact
Xuhui_Hu@henlius.com
18618313742

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Shanghai Henlius Biotech

Start the discussion