A Single-arm Phase II Study of HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients With KRAS G12D Mutations

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age: 18-75 (including 18 and 75); 2.Metastatic pancreatic cancer (from pancreatic ductal epithelium); 3.Tumor tissue contains KRAS G12D mutation; 4.No systemic antitumor therapy in advanced stage; if previous neoadjuvant / adjuvant therapy, last treatment should be over 6 months; 5.At least one measurable lesion according to the RECIST v1.1 criteria; 6.The ECOG (Eastern Cooperative Oncology) score was 0-1; 7.Expected survival period of 3 months; 8.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%; 9.Women of childbearing age must have a blood pregnancy test within 7 days before enrollment, the result should be negative and must be non-lactating and should be willing to use appropriate contraception during the trial and within 6 months of treatment. For men, surgical sterilization or consent to use appropriate contraception during the study and within 6 months after completion of treatment.

⁃ Volunteer to participate in the study and sign the informed consent form, good compliance, agreed to cooperate with the follow-up.

Locations
Other Locations
China
First Affiliated Hospital of Zhejiang University Schlool of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Tingbo Liang, MD
liangtingbo@zju.edu.cn
86+19941463683
Backup
Yiwen Chen, MD
cherry0705@zju.edu.cn
86+15088682641
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 32
Treatments
Experimental: Arm A
Eligible patients will receive HRS-4642, combined with Nimotuzumab and AG regimen, predose regimen: HRS-4642 500mg intravenous infusion, D1,1200mg IV infusion, D8, every 3 weeks; Nimotuzumab 400mg intravenous infusion, D1,8, every 3 weeks; Albumin paclitaxel 125mg/m2 intravenous infusion, gemcitabine 1000mg / m2, D1,8, a cycle every 3 weeks until disease progression or toxicity intolerance.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov