Program Status
RecruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
5-Fluorouracil, Bevacizumab, capecitabine, Irinotecan, Leucovorin, oxaliplatinTags
MSS/ MMRpComments
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)
Helpful Links
https://www.annalsofoncology.org/article/S0923-7534(24)02102-1/fulltext https://aacrjournals.org/mct/article/22/12_Supplement/B123/730794/Abstract-B123-Mechanism-of-action-of-ivonescimab https://jitc.bmj.com/content/10/11/e005517Location | Location Status |
---|---|
China | |
The Sixth Hospital,Sun Yat-sen University Guanzhou, Guangdong 510000 |
Recruiting |
Contacts
Inclusion Criteria
Inclusion Criteria:
Histologically proven diagnosis of colorectal adenocarcinoma
Part1: Initially unresectable metastatic colorectal cancer(metastasis detected at diagnosis) not previously systemic antitumor therapy for metastatic disease.
Part2: Prior radiation therapy for lesions which were primary or metastatic from colorectal cancer.Patient must have received at least 2 prior line and no more than 4 prior lines of systemic anticancer therapy.
Eastern Cooperative Oncology Group performance status of 0 or 1
Measurable disease as defined by RECIST v1.1
Adequate hematologic and end-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