Trials / Completed
CompletedNCT05162469
A Study of SHR-A1909 in Subjects With Advanced Malignant Tumors
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1909 injection | SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)). |
Timeline
- Start date
- 2022-02-23
- Primary completion
- 2024-03-28
- Completion
- 2024-06-13
- First posted
- 2021-12-17
- Last updated
- 2025-07-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05162469. Inclusion in this directory is not an endorsement.