Clinical trial · Interventional
Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
NCT03474289CI-TRIAL-00032200unknownPhase 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 purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies
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 |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1316 | Drug | Adebrelimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Escalation
- description
- SHR-1316 administrated intravenously(IV) at protocol defined dose levels
- interventionNames
- Drug: SHR-1316
- type
- EXPERIMENTAL
- label
- Expansion
- description
- SHR-1316 administrated IV in advanced solid tumors and selected tumor type
- interventionNames
- Drug: SHR-1316
Primary outcomes (2)
- measure
- Adverse Events
- timeFrame
- at the end of cycle one(each cycle is 21 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female ≥18 years of age 2. Subjects with confirmed advanced malignancies (histologically or cytologically) 3. ECOG Performance status of 0 or 1 4. Adequate organ functions 5. Life expectancy ≥12 weeks; Exclusion Criteria: 1. Subjects with active autoimmune disease. 2. Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment 3. Previous received PD-1 or PD-L1 therapy 4. Known Active central nervous system (CNS) metastases 5. Known Clinically significant cardiovascular condition 6. Active infection or an unexplained fever \>38.5°C 7. History of immunodeficiency
References
Publications (0)
Data not yet available
No reference posted for this study.