Clinical trial · Interventional
A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor
An Open-Label, Multi-site Phase I Clinical Study of SHR-A1811(sc) Subcutaneous Injection: Evaluating Pharmacokinetics, Safety, Tolerability, and Efficacy in Patients With Solid Tumor
NCT07275242CI-TRIAL-00100929recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1811 for Injection | Drug | — | UNRESOLVED |
| SHR-A1811 Subcutaneous Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low-Dose Group
- interventionNames
- Drug: SHR-A1811 Subcutaneous Injection
- Drug: SHR-A1811 for Injection
- type
- EXPERIMENTAL
- label
- Medium-Dose Group
- interventionNames
- Drug: SHR-A1811 Subcutaneous Injection
- Drug: SHR-A1811 for Injection
- type
- EXPERIMENTAL
- label
- High-Dose Group
- interventionNames
- Drug: SHR-A1811 Subcutaneous Injection
- Drug: SHR-A1811 for Injection
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years of age; 2. Solid Tumor confirmed by histology or cytology; 3. ECOG score is 0 or 1; 4. An expected survival of ≥ 12 weeks; 5. At least one measurable lesion according to RECIST v1.1 criteria; 6. Have adequate renal and hepatic function; 7. Patients voluntarily joined the study and signed informed consent. Exclusion Criteria: 1. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer; 2. Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication; 3. History of immunodeficiency; 4. Clinically significant cardiovascular diseases; 5. Known or suspected interstitial lung disease; 6. Known hereditary or acquired bleeding thrombotic tendency; 7. Active hepatitis and liver cirrhosis; 8. Known allergic history of the drug components of this protocol; 9. History of neurological or psychiatric disorders.
References
Publications (0)
Data not yet available
No reference posted for this study.