OncoMatch/Clinical Trials/NCT06770452
HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients
Is NCT06770452 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including HRS-4642 and Nimotuzumab for metastatic pancreatic carcinoma.
Treatment: HRS-4642 · Nimotuzumab · gemcitabine + nab-paclitaxel — This study is a single-arm phase II clinical study to include 32 patients with advanced pancreatic cancer with KRAS G12D mutation to evaluate the effectiveness of HRS-4642 combined with nitutuzumab and AG for first-line treatment of advanced pancreatic cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: KRAS g12d
Disease stage
Required: Stage IV
Metastatic disease required
Metastatic pancreatic cancer (from pancreatic ductal epithelium); At least one measurable lesion according to the RECIST v1.1 criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: targeted therapy against KRAS G12D
Previous treatment of targeted therapy against KRAS G12D
Cannot have received: targeted therapy against EGFR
Previous targeted therapy against EGFR
Lab requirements
Blood counts
Neutrophil count ≥1.5×10^9 / L; Platelet ≥100×10^9 / L; Hemoglobin ≥100 g / L; Serum albumin ≥30 g / L
Kidney function
Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5×ULN; Urinary protein <2+; if urine protein ≥2+, 24h urine protein quantification <1g can be enrolled
Liver function
Total bilirubin ≤1.5×ULN; ALT, AST ≤3×ULN and ALP ≤2.5×ULN; if the patient has liver metastasis, ALT and AST ≤5×ULN; if the patient has liver or bone metastasis, ALP ≤5×ULN
Cardiac function
ECG: QTcF ≤450 ms (male), QTcF ≤470 ms (female); Cardiac color ultrasound: LVEF ≥50%
The functions of vital organs meets the following requirements (any blood components, cell growth factors are not allowed 2 weeks prior to enrollment): Neutrophil count≥1.5×10^9 / L; Platelet≥100×10^9 / L; Hemoglobin≥100 g / L; Serum albumin≥30 g / L; Total bilirubin≤1.5×ULN; ALT, AST≤3×ULN and ALP≤2.5×ULN; if the patient has liver metastasis, ALT, ALT and AST≤5×ULN; if the patient has liver or bone metastasis, ALP≤5×ULN; Creatinine clearance≥50 mL/min or serum creatinine ≤1.5×ULN; Urinary protein <2+; if urine protein≥2+, an additional 24 hours urine protein quantification should be tested, and if 24 hours urine protein quantification <1g can be enrolled; ECG: QTcF≤450 ms (male), QTcF≤470 ms (female); Cardiac color ultrasound: LVEF (left ventricular ejection fraction) ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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