Clinical trial · Interventional
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
Phase Ia/Ib Trial to Evaluate the Tolerability and Safety of IBI101 Monotherapy or in Combination With Sintilimab in Advanced Solid Tumor Patients
NCT03758001CI-TRIAL-00064152completedPhase 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)
Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI101 | Drug | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IBI101
- description
- IBI101 will be administrated intravenously. 3+3 dose escalation design will be used with eight dose levels being tested.
- interventionNames
- Drug: IBI101
- type
- EXPERIMENTAL
- label
- IBI101 in combination with Sintilimab
- description
- IBI101 and Sintilimab will be administrated intravenously. 3+3 dose escalation design will be used with 4 dose levels of IBI101 being tested. Two dose levels of IBI101 in combination with Sintilimab will be expanded to 10 patients each.
- interventionNames
- Drug: IBI101
- Drug: Sintilimab
Primary outcomes (1)
- measure
- Incicende of Adverse Events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment * 18 to 75 years old * Life expectancy ≥ 12 weeks * At least 1 measurable lesion * ECOG PS score 0 or 1 * Adequate organ and bone marrow function Exclusion Criteria: * Previous exposure to anti-OX40, anti-PD-1, anti-PD-L1, anti-PD-L2 antibody or other immune checkpoint inhibitors * Exposure to any other investigational drug in the 4 weeks prior to 1st dose of investigational drug * Exposure to anti-tumor agents in the 3 weeks prior to 1st dose of investigational drug * Exposure to immunosuppressant in the 3 weeks prior to 1st dose of investigational drug * Major surgery in the 4 weeks prior to 1st dose of investigational drug * 30Gy radiation in the chest in the 6 months prior to 1st dose of investigational drug * History of autoimmune disease * Symptomatic CNS metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.