Status:
UNKNOWN
HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Locally Advanced or Metastatic Solid Tumors
Squamous-cell Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 a...
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);
- Age ≥ 18 years;
- Phase 1a dose escalation: patients must have histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
- Phase 1b dose expansion: patients must have a histological or cytological diagnosis of Squamous Non-Small Cell Lung Cancer (EGFR H score ≥200 confirmed by central lab) which is 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;
Exclusion
- Systemic anti-cancer treatment or investigational agents in the 28 days prior to the first study dosing;
- Patients who still have persistent ≥ grade 2 toxicities from prior therapies;
- Active CNS metastasis;
- History of any secondary malignancy in the past 5 years;
- Active autoimmune disease;
- Human immunodeficiency virus (HIV) infection;
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05360381
Start Date
June 3 2022
End Date
December 30 2024
Last Update
August 8 2023
Active Locations (2)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200000
2
THE Affiliated Hospital of Xuzhou Medical University
Xuzhou, China