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 (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06770452 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KRAS?
Yes, KRAS g12d is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 75 years or younger.
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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