Trials / Unknown
UnknownNCT05360381
HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of HLX35 (Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody) in Patients With Advanced or Metastatic Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 administered as a single-agent by IV infusion every 2 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. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HLX35 | A Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody, HLX35 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle |
Timeline
- Start date
- 2022-06-03
- Primary completion
- 2024-10-30
- Completion
- 2024-12-30
- First posted
- 2022-05-04
- Last updated
- 2023-08-08
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05360381. Inclusion in this directory is not an endorsement.