Trials / Recruiting
RecruitingNCT05277168
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE I/IIA CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-A1904 | Single Arm ：It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors |
Timeline
- Start date
- 2022-05-30
- Primary completion
- 2026-03-03
- Completion
- 2026-05-30
- First posted
- 2022-03-14
- Last updated
- 2026-01-02
Locations
28 sites across 4 countries: United States, Australia, Moldova, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05277168. Inclusion in this directory is not an endorsement.