A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

5-Fluorouracil, Bevacizumab, capecitabine, Irinotecan, Leucovorin, oxaliplatin

Tags

MSS/ MMRp

Comments

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)

Location 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

NCT ID

NCT05382442

Date Trial Added

2022-05-19

Updated Date

2022-08-03