Colorectal Cancer Clinical Trial
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
Verified date | September 2022 |
Source | Innovent Biologics (Suzhou) Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 4 |
Est. completion date | May 2023 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing cancer hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Innovent Biologics (Suzhou) Co. Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR | Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee | Up to 3 years | |
Secondary | ORR in all MSI-H CRC patients based on investigator assessment. | Up to 3 years | ||
Secondary | Progression-Free Survival (PFS) both by investigator and IRC | Up to 3 years | ||
Secondary | Disease Control Rate (DCR) both by investigator and IRC | Up to 3 years | ||
Secondary | Duration of Response (DoR) both by investigator and IRC | Up to 3 years | ||
Secondary | Time To Response (TTR) both by investigator and IRC | Up to 3 years | ||
Secondary | Overall Survival | Up to 3 years | ||
Secondary | Incidence of adverse events (AE) | Up to 3 years |
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