Trials / Unknown
UnknownNCT06059508
Phase I Clinical Study of SHR-5495 in the Treatment of Patients With Advanced Malignant Tumors
A Multicenter, Open-label Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-5495 for Injection in Patients With Advanced Malignancies
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open, multicenter, dose-increasing/dose-expanding/efficacy expanding Phase I clinical study aimed at evaluating the tolerance, safety, PK, PD, and immunogenicity of SHR-5495 in the treatment of advanced malignant tumor patients, and preliminarily observing its anti-tumor efficacy. The entire study was divided into three stages: dose escalation, dose extension, and efficacy extension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-5495 for injection | SHR-5495 for injection |
Timeline
- Start date
- 2023-10-25
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2023-09-28
- Last updated
- 2023-11-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06059508. Inclusion in this directory is not an endorsement.