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

Estado del programa

Reclutamiento

Fase

Fase 2

Inmunoterapia previa permitida

No

Ensayo dirigido por el CRC

Drogas

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

Etiquetas

MSS/ MMRp

Comentarios

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 se permite inmunoterapia previa.
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)

Ubicación Situación
Estados Unidos
Summit Therapeutics Research Site
Los Angeles, California 90067
Reclutamiento
China
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong 510000
Reclutamiento

Contactos

Criterios de inclusión

Criterios de inclusión:

* 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

Criterios de exclusión

Criterios de exclusión:

* 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

Fecha en que se añadió el juicio

2022-05-19

Fecha de actualización

2025-03-25