Clinical trial · Interventional
A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors
A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors
NCT06605222CI-TRIAL-00081730recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-7787 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group: SHR-7787 injection
- interventionNames
- Drug: SHR-7787 injection
Primary outcomes (4)
- measure
- Maximum tolerated dose
- timeFrame
- first dose of study medication up to 21 days
- description
- The Maximum tolerated dose of SHR-7787 injection monotherapy
- measure
- Recommended phase II dose
- timeFrame
- first dose of study medication up to 21 days
- description
- The Recommended phase II dose of SHR-7787 injection monotherapy
- measure
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Patients with unresectable recurrent or metastatic solid tumors; 3. There is at least one lesion could be measured; 4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 5. Adequate organ functions as defined; 6. Life expectancy ≥3 months. Exclusion Criteria: 1. Patients with known active central nervous system (CNS) metastases; 2. Subjects who had other malignancy in five years before the first dose; 3. Patients with tumor-related pain that cannot be controlled as determined; 4. Patients with serious cardiovascular and cerebrovascular diseases; 5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion; 6. Patients with Severe infections; 7. History of immunodeficiency; 8. History of autoimmune diseases; 9. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy 10. Active infection; 11. Pregnant or nursing women; 12. Known history of serious allergic reactions to the investigational product or its main ingredients.
References
Publications (0)
Data not yet available
No reference posted for this study.