Treatment of cancer
A cancer, colorectal cancer technology, applied in the direction of antibody medical ingredients, medical preparations containing active ingredients, drug combinations, etc.
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example 1
[0243] Example 1: Dose Finding is a Phase 1 Multicenter Open-Label Single-Arm Dose-Escalation and Dose-Expansion Study of Durvalumab in Combination with Monarizumab
[0244] Conduct a phase 1 multicenter open-label single-arm dose-escalation and dose-expansion study of the combination of durvalumab and monalizumab (see WHO Drug Information [World Health Organization drug information] Volume 30, Number 1, 2016; Also known as IPH2201; an antibody having a heavy chain of SEQ ID NO: 11 and a light chain of SEQ ID NO: 15) to evaluate safety, tolerability, PK, immunogenicity, pharmacodynamics, and antitumor activity. The study consisted of 2 parts: dose escalation and dose expansion.
[0245] Subjects received durvalumab and monalizumab via 2 separate intravenous infusions. Subjects received durvalumab and monalizumab until unacceptable toxicity, documented confirmed progressive disease (PD), or subject withdrawal for another reason was documented.
[0246] Inclusion criteria inc...
example 2
[0259] Example 2: Responses in the CRC dose-expansion portion of a phase I clinical study in MSS colorectal cancer patients treated with monalizumab and durvalumab
[0260] The dose-expansion portion of the phase 1 study aims to enroll patients into four cohorts corresponding to cancers that are not adequately treated with existing therapies. One of these groups included subjects with recurrent or metastatic MSS-CRC. In the MSS-CRC group, all subjects were required to have documented mutation testing during screening and confirmation of tumor location from disease assessment for enrollment, and CRC cancers must be free of defective DNA mismatch repair (microsatellite instability ), as documented by passing tests.
[0261] Defective DNA mismatch repair is defined by any of the following: (il high-frequency microsatellite instability, where 2 or more microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 , or MONO-27) group, or (ii) immunohistochemical analysis showed lack of pr...
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