Clinical trial · Interventional
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
A Phase I, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, Combined With Sintilimab in Patients With Advanced Solid Tumor
NCT05246995CI-TRIAL-00056600unknownPhase 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 primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in 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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI325+Sintilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IBI325 and Sintilimab combination does-escalation
- interventionNames
- Drug: IBI325+Sintilimab
Primary outcomes (2)
- measure
- Number of patients with DLT
- timeFrame
- 42 days post first dose
- description
- Number of patients who experienced a dose-limiting toxicity within the first 42 days after the first dose
- measure
- Number of patients with treatment related AEs
- timeFrame
- Up to 90 days post last dose
- description
- Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion 1. Histologically confirmed, locally advanced unresectable or metastatic tumors. 2. At least one measurable lesion per RECIST 1.1 3. Male or female subject at least 18 years old and no more than 75 years old. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1. 5. Must have adequate organ function 6. Be able to provide archived or fresh tumor tissues Exclusion 1\. Any anti-tumor treatment with 4 weeks, except anti-CD73 monoclonal antibody. 2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies. 3\. Unstable central nervous system netastases 4. Known active autoimmune disease or inflammatory disease 5. Known active infectious disease 6. Other uncontrolled systematic disease that may increase the risk of participating the study
References
Publications (0)
Data not yet available
No reference posted for this study.