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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.

Phase 2RecruitingZhejiang UniversityNCT06770452Data as of May 2026

Treatment: HRS-4642 · Nimotuzumab · gemcitabine + nab-paclitaxelThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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