Clinical trial · Interventional
IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
An Open-label, Multicenter, Phase 2 Study of IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR) /microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi
Summary
Brief summary (as posted)
The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI310 (anti-CTLA-4 antibody) | Biological | — | UNRESOLVED |
| Sintilimab(anti-PD-1 antibody) | Biological | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IBI310 + Sintilimab
- interventionNames
- Biological: IBI310 (anti-CTLA-4 antibody)
- Biological: Sintilimab(anti-PD-1 antibody)
Primary outcomes (1)
- measure
- ORR
- timeFrame
- Up to 3 years
- description
- Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee
Secondary outcomes (7)
- measure
- ORR in all MSI-H CRC patients based on investigator assessment.
- timeFrame
- Up to 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed colorectal adenocarcinoma 2. Imaging confirmed locally-advanced or metastatic colorectal cancer 3. Measurable disease by CT or MRI 4. MSI-H confirmed by central lab 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 Exclusion Criteria: 1. Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways 2. Subjects with active,known or suspected autoimmune disease 3. Subjects with a history of primary immune deficiency 4. Subjects with severe infectious diseases
References
Publications (0)
Data not yet available