OncoMatch/Clinical Trials/NCT06099821
KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade
Is NCT06099821 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including KN046 and Regorafenib for digestive system cancers.
Treatment: KN046 · Regorafenib · Apatinib — The study is an interventional phase II clinical trial aiming to evaluate the efficacy and safety of KN046, a PD-L1 and CTLA-4 bispecific antibody, in combination with regorafenib or apatinib for microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade. KN046 plus regorafenib will be given for patients with colorectal cancers, and KN046 plus apatinib will be given for patients with gastric cancers (including esophageal-gastric junction cancers) and other kinds of digestive system cancers.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: MSH2 deficient mismatch repair
dMMR/MSI-H cancers resistant to PD1/PDL1 blockade
Required: MSH6 deficient mismatch repair
dMMR/MSI-H cancers resistant to PD1/PDL1 blockade
Required: MLH1 deficient mismatch repair
dMMR/MSI-H cancers resistant to PD1/PDL1 blockade
Required: PMS2 deficient mismatch repair
dMMR/MSI-H cancers resistant to PD1/PDL1 blockade
Required: MSI high microsatellite instability
dMMR/MSI-H cancers resistant to PD1/PDL1 blockade. MSI status should be confirmed by PCR or NGS.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
dMMR/MSI-H cancers resistant to PD1/PDL1 blockade
Must have received: anti-PD-L1 therapy
dMMR/MSI-H cancers resistant to PD1/PDL1 blockade
Cannot have received: immune checkpoint inhibitor in combination with anti-VEGF tyrosine kinase inhibitor (Regorafenib, Apatinib, Sulfatinib, Anlctinib)
Previous treatment with any immune checkpoint inhibitors in combination with anti-VEGF tyrosine kinase inhibitor, including but not limited to Regorafenib, Apatinib, Sulfatinib and Anlctinib.
Lab requirements
Blood counts
HGB ≥ 80g/L, NEU ≥ 1.0×10^9/L, PLT ≥ 75×10^9/L
Kidney function
Cr≤1.5×ULN or CrCl≥50mL/min (Cockcroft-Gault method)
Liver function
TBiL ≤ 1.5×ULN, ALT and AST ≤3 ×ULN; for patients with liver metastasis ALT and AST ≤5 ×ULN
Cardiac function
INR, APTT, PT ≤ 1.5 ×ULN
Within the first 7 days of initial dosing, subjects should have good organ function: HGB ≥ 80g/L, NEU ≥ 1.0*10^9/L, PLT ≥ 75*10^9/L, Cr≤1.5×ULN or CrCl≥50mL/min（Cockcroft-Gault method), TBiL ≤ 1.5×ULN, ALT and AST ≤3 ×ULN; for patients with liver metastasis ALT and AST ≤5 ×ULN, urine protein <2+;,if urine protein ≥ 2+, 24 hour urinary protein quantity <2g; INR, APTT, PT ≤ 1.5 ×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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