Clinical trial · Interventional
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
A Phase I, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, in Patients With Advanced Solid Tumor
NCT05119998CI-TRIAL-00068885completedPhase 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 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI325 | Drug | — | UNRESOLVED |
| IBI325 + sintilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IBI325 and sintilimab combination does-escalation
- interventionNames
- Drug: IBI325 + sintilimab
- type
- EXPERIMENTAL
- label
- IBI325 monotherapy does-escalation
- interventionNames
- Drug: IBI325
Primary outcomes (2)
- measure
- Number of patients with DLT
- timeFrame
- 28 days post first dose
- description
- Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed, locally advanced unresectable or metastatic tumors. 2. At least one evaluable or 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 Criteria: 1. Previous exposure to any 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.