Status:
UNKNOWN
HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 e...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05360368
Start Date
March 30 2023
End Date
February 28 2024
Last Update
May 5 2022
Active Locations (1)
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1
Fudan University shanghai cancer center
Shanghai, China, 200000