Trials / Active Not Recruiting
Active Not RecruitingNCT04603287
A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In phase Ia study, the safety and tolerability of SI-B001 in patients with locally advanced or metastatic epithelial malignancies will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of SI-B001. In the phase Ib study, the safety and tolerability of SI-B001 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of SI-B001 in patients with locally advanced or metastatic epithelial tumors will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SI-B001 | Administration by intravenous infusion. |
Timeline
- Start date
- 2020-04-17
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2020-10-26
- Last updated
- 2025-09-26
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04603287. Inclusion in this directory is not an endorsement.