Clinical trial · Interventional
A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
An Open-Label, Multi-Center Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
NCT05594875CI-TRIAL-00078247completedPhase 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 Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1921 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1921
- interventionNames
- Drug: SHR-1921
Primary outcomes (4)
- measure
- Number of subjects with adverse events (AEs)
- timeFrame
- Screening up to study completion, an average of 1 year
- description
- To check the numbers of AEs happened during the course of trial.
- measure
- Number of subjects with laboratory tests findings of potential clinical importance
- timeFrame
- Screening up to study completion, an average of 1 year
- description
- To check the Clinically significant and non clinically significant abnormal values during the course of trial.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content 3. Male or female 4. Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy 5. ECOG performance status of 0-1 Exclusion Criteria: 1. Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites 2. Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression 3. Has known history of other documented malignancy 4. Has known history of acquired immunodeficiency syndrome (AIDS) 5. Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure 6. Has active or prior documented interstitial pneumonia/interstitial lung disease 7. Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose 8. Has known active hepatitis B 9. Has known allergies to SHR-1921 component 10. Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.