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NCT05360368 | Unknown status | Solid Tumor

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

Shanghai henliushuibiotech

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.

Condition or disease

Solid Tumor

Intervention/treatment

Helix07

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 24 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : March 30, 2023
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : February 28, 2024
Arm Intervention/treatment

Experimental: Helix07

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
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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;
HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors

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

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Locations

Not yet recruiting

China,

F UdanuniversityShanghai cancer center

Shanghai, China, 200000