Clinical trial · Interventional
A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors
An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
NCT07231211CI-TRIAL-00122421recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-4610 Injection | Drug | — | UNRESOLVED |
| SHR-A1811 for injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Cohort 1 Group
- description
- SHR-4610 dose A in dose escalation stage.
- interventionNames
- Drug: SHR-4610 Injection
- type
- EXPERIMENTAL
- label
- Cohort 2 Group
- description
- SHR-4610 dose B in dose escalation stage.
- interventionNames
- Drug: SHR-4610 Injection
- type
- EXPERIMENTAL
- label
- Cohort 3 Group
- description
- SHR-4610 dose C in dose escalation stage.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; 2. Age range: 18-75 years old, both male and female are welcome; 3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment; 4. Have at least one measurable tumor lesion per RECIST v1.1; 5. ECOG performance status of 0-1; 6. Life expectancy ≥ 12 weeks; 7. Adequate bone marrow and organ function. Exclusion Criteria: 1. Patients with active central nervous system metastases or meningeal metastases; 2. Systemic antitumor therapy was received 4 weeks before the start of the study; 3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion; 4. Have poorly controlled or severe cardiovascular disease; 5. Subjects with active hepatitis B or active hepatitis C; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
References
Publications (0)
Data not yet available
No reference posted for this study.