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Trial in China, for patients with metastatic MSS only CRC.
First part for patients receiving first line therapy for metastatic disease; second part admits patients who already received standard of care therapy.
No prior immunotherapy allowed.
AK112 (ivonescimab): tetravalent Fc-silent bispecific antibody with dual blockade of PD-1 and VEGF. Immunotherapy, since includes anti PD-1.

AK117 (ligufalimab): anti-CD47 antibody; immunotherapy.

Ongoing trial; signs of efficacy and safety (see ESMO 2024, Helpful Links)

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Inclusion Criteria

Inclusion Criteria:

* Histologically proven diagnosis of colorectal adenocarcinoma
* Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
* Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not tolerate or have contraindications to standard treatment
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and organ function

Exclusion Criteria

Exclusion Criteria:

* Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)
* Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway
* History of autoimmune disease
* Prior allogeneic stem cell or solid organ transplantation
* Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C
* Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
* Pregnancy or lactation
* Dysphagia