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 (Jun 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
Treatments studied
Targeted therapy
Other
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.
Frequently asked questions
Is NCT06099821 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor in combination with anti-VEGF tyrosine kinase inhibitor disqualifies patients from enrollment.
Does this trial require MSH2?
Yes, MSH2 deficient mismatch repair is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 deficient mismatch repair is a required biomarker for enrollment.
Does this trial require MLH1?
Yes, MLH1 deficient mismatch repair is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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