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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 (Sep 2026). This Phase 2 trial studies multiple treatments including HRS-4642 and Nimotuzumab for metastatic pancreatic carcinoma.

Phase 2RecruitingZhejiang UniversityNCT06770452Data as of Sep 2026Location: China

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

Treatments studied

Chemotherapy

gemcitabine + nab-paclitaxel

Other

HRS-4642Nimotuzumab

Cancer type

Pancreatic Cancer

Biomarker criteria

Required: KRAS g12d

Tumor tissue contains KRAS G12D mutation

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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

Cannot have received: systemic antitumor therapy in advanced stage

Exception: if previous neoadjuvant / adjuvant therapy, last treatment should be over 6 months

No systemic antitumor therapy in advanced stage; if previous neoadjuvant / adjuvant therapy, last treatment should be over 6 months

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+, 24 hours 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, 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): ... [full details as above]

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.

Are there prior therapy exclusions?

Yes. Prior targeted therapy against KRAS G12D, targeted therapy against EGFR, systemic antitumor therapy in advanced stage disqualifies patients from enrollment.

Does this trial require KRAS?

Yes, KRAS g12d is a required biomarker for enrollment.

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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