TATE and KN046 in MCRC
Megadott ok: Business Operation Strategy Adjustment
Key facts
- Where
- Guangzhou, KínaSee the site
- Phase
- 2. fázis
Where in Kína
- Sun Yat-sen University Cancer CenterGuangzhou, KínaNo longer taking part
Trial details
- Who runs it
- Zhejiang Raygene Pharmaceuticals Co., Ltd
- Trial code
- NCT06834399
- Record updated
- 2025. február 19.
- Original description
A single-arm, multicenter, Phase IIA study of Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization (TATE) and KN046 (recombinant humanized anti-PD-L1/CTLA-4 bispecific single-domain antibody Fc fusion protein injection) in patients with liver metastases from colorectal cancer.Read full original descriptionShow less
Phase IIA Clinical Trial of Intra-arterial Administration of Tirapazamine Followed by Transarterial Embolization （TATE）and KN046 for the Treatment of Advanced Colorectal Cancer with Liver Metastasis (MSS/pMMR)
A single-arm, multicenter, Phase IIA study of Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization (TATE) and KN046 (recombinant humanized anti-PD-L1/CTLA-4 bispecific single-domain antibody Fc fusion protein injection) in patients with liver metastases from colorectal cancer.
Inclusion: Liver metastatic MSS/pMMR-mCRC; mCRC progressed on at least two lines of standard chemotherapy; Measurable disease; ECOG 0-1; Adequate organ function.
Exclusion: Prior organ transplantation; Prior autoimmune disorder; Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways; Major GI bleeding in the last 2 months; Oxygen saturation less than 92% in room air.