OncoMatch/Clinical Trials/NCT05985109
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer
Is NCT05985109 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including KN046 and regorafenib for colorectal cancer.
Treatment: KN046 · regorafenib — The study is an interventional Phase II clinical trial aiming to optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient
pMMR/MSS mCRC
Required: MSI microsatellite stable
pMMR/MSS mCRC
Required: BRAF wild-type
no BRAF V600E mutation
Required: BRAF V600E
BRAF V600E mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine
failed fluoropyrimidine
Must have received: oxaliplatin
failed oxaliplatin
Must have received: irinotecan
failed irinotecan
Cannot have received: immune checkpoint inhibitor
Previous treatment with any immune checkpoint inhibitors or T-cell co-stimulatory drugs, including but not limited to PD-1/PD-L1, CTLA-4, LAG3, and other immune checkpoint inhibitors, therapeutic vaccines, etc.
Cannot have received: regorafenib (regorafenib)
Previous treatment with regorafenib
Lab requirements
Blood counts
HGB ≥ 80g/L; NEU ≥ 1.0×10^9/L; PLT ≥ 75×10^9/L; INR, APTT, PT ≤ 1.5 ×ULN
Kidney function
Cr≤1.5×ULN or CrCl≥50mL/min (Cockcroft-Gault method); urine protein <2+; if urine protein ≥2+, 24 hour urinary protein quantity <2g
Liver function
TBiL ≤ 1.5×ULN; ALT and AST ≤3 ×ULN; for patients with liver metastasis ALT and AST ≤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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