Official Title
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
Brief Title
IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
Protocol ID
NCT04258111
Lead Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Brief Summary
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.
Study Period
-
Enrollment Count
4 participants
Eligibility Criteria
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
Filters
Colorectal Cancer
PHASE2
TERMINATED
ADULT
OLDER_ADULT