OncoMatch/Clinical Trials/NCT05985109
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer
Official title: A Phase II Multi-cohort Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib for Metastatic Microsatellite-Stable Colorectal Cancer: a Phase II Multi-cohort Study
Is NCT05985109 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Targeted therapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient
pMMR/MSS mCRC
Required: MSI microsatellite stable
pMMR/MSS mCRC
Required: BRAF V600E
BRAF V600E mutation
Excluded: BRAF V600E mutation
no 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.
Frequently asked questions
Is NCT05985109 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor, regorafenib disqualifies patients from enrollment.
Does this trial require MMR?
Yes, MMR proficient is a required biomarker for enrollment.
Does this trial require MSI?
Yes, MSI microsatellite stable is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF V600E is a required biomarker for enrollment.
Are patients with BRAF alterations eligible?
No. BRAF V600E mutation is an exclusion criterion.
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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