Clinical trial · Interventional
A Study of SHR-1802 in Patients With Advanced Solid Tumor
A Phase Ⅰb/Ⅱ Dose-exploration and Efficacy-expansion Study of SHR-1802 Combined With Camrelizumab for Injection and Famitinib Malate Capsules for the Treatment of Advanced Solid Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Adjustment of R\&D strategy
Summary
Brief summary (as posted)
To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT),recommended phase II dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria.
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-1802+camrelizumab + famitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules
- interventionNames
- Drug: SHR-1802+camrelizumab + famitinib
Primary outcomes (3)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- 4 weeks
- measure
- Recommended phase II dose (RP2D)
- timeFrame
- up to 1 years
- measure
- ORR
- timeFrame
- up to 2 years
- description
- Objective Response Rate, determined according to RECIST v1.1 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 3. Has a life expectancy≥ 3 months; 4. At least one measurable lesion according to RECIST v1.1; 5. Pathologically confirmed advanced solid tumor; 6. Adequate bone marrow reserve and organ function. Exclusion Criteria: 1. Have received prior therapy with camrelizumab, and famitinib; 2. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment; 3. Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment; 4. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites; 5. Have known history of arterial/venous thrombosis within 6 months prior to the first dose of the treatment, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism; 6. Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the treatment; 7. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.
References
Publications (0)
Data not yet available