Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-27 @ 12:06 PM
Study NCT ID:
NCT07240766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
Sponsor:
Zhejiang University
Organization:
Study Overview
Official Title:
Phase II Study of HRS-4642 in Combination With Nimotuzumab and Chemotherapy for Subjects With Borderline Resectable Pancreatic Cancer With KRAS G12D Mutation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and AG in borderline resectable pancreatic cancer. The study process includes a screening period (from the signing of the informed consent form until the first dose), a treatment period (from the first dose to the discontinuation of study treatment), and a follow-up period (safety follow-up and survival follow-up after the discontinuation of study treatment).
Detailed Description:
This study is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and AG in borderline resectable pancreatic cancer. The study process includes a screening period, a treatment period, and a follow-up period.
Screening Period: The screening period for this study is 28 days. Eligible subjects who complete the screening examinations and assessments will proceed to the treatment period.
Treatment Period: Subjects who pass screening will enter the neoadjuvant therapy phase, receiving treatment with HRS-4642 in combination with Nimotuzumab and the AG regimen. The predefined administration regimen is as follows:
HRS-4642: 500 mg intravenous infusion on Day 1, and 1200 mg intravenous infusion on Day 8, every 3 weeks per cycle.
Nimotuzumab: 400 mg intravenous infusion on Days 1 and 8, every 3 weeks per cycle.
Albumin-bound paclitaxel: 125 mg/m² intravenous infusion on Days 1 and 8, every 3 weeks per cycle.
Gemcitabine: 1000 mg/m² intravenous infusion on Days 1 and 8, every 3 weeks per cycle.
Neoadjuvant therapy will consist of 4 cycles. After completing 2 cycles and 4 cycles of neoadjuvant therapy, subjects will undergo radiographic imaging for efficacy evaluation. After completing 4 cycles of neoadjuvant therapy, eligibility for radical surgery will be assessed by a Multidisciplinary Team (MDT). If assessed as eligible for radical surgery, the subject will undergo surgery within 4 weeks after completing neoadjuvant therapy.
After surgery, subjects will enter the adjuvant therapy phase. Adjuvant therapy should begin within 4 to 12 weeks after surgery. The recommended adjuvant treatment regimen is to continue HRS-4642 + Nimotuzumab + AG for 4 cycles. If a subject cannot receive HRS-4642 + Nimotuzumab + AG as adjuvant therapy, the investigator will develop an adjuvant treatment plan based on a comprehensive assessment. The adjuvant therapy phase shall not exceed 4 cycles.
If the assessment determines that radical surgery is not possible, and the subject has not experienced disease progression, the subject may continue to receive study treatment if the investigator assesses that continued treatment is likely to be beneficial.
Subjects will receive HRS-4642 in combination with Nimotuzumab and AG until radiographic disease progression, unacceptable toxicity, voluntary withdrawal, loss to follow-up/death occurs (whichever comes first).
During the treatment period, subject visits will occur on Day 1 and Day 8 of each cycle, and on Cycle 1 Day 15. Tumor imaging assessments will be performed at Cycle 3 Day 1 (±7 days) and Cycle 4 Day 21 (±7 days) (upon completion of neoadjuvant therapy). For subjects who undergo radical surgery, assessments will be performed every 12 weeks (±7 days) postoperatively. For subjects who do not undergo radical surgery, subsequent assessments will be performed every 6 weeks (±7 days) until radiographic disease progression, initiation of new anti-tumor therapy, voluntary withdrawal, loss to follow-up/death occurs (whichever comes first). If clinically indicated, imaging examinations and assessments may be performed at any time. All subjects must undergo the corresponding examinations and imaging assessments at the end-of-treatment visit (if more than 4 weeks have passed since the last assessment).
Follow-up Period: After discontinuing study treatment, subjects must return to the research center for a safety follow-up visit 30 days (±7 days) after the last dose or before starting new anti-tumor therapy. Subjects will enter the survival follow-up period after the last dose of study treatment. The investigator must conduct survival follow-ups every 2 months (±7 days) until the subject dies, is lost to follow-up, the investigator terminates the study, or other study termination criteria are met (whichever comes first). For subjects who discontinue the study for reasons other than radiographic disease progression, tumor progression follow-up should continue, including radiographic assessments per the protocol-specified frequency, until disease progression, initiation of new anti-tumor therapy, etc.
Screening Period: The screening period for this study is 28 days. Eligible subjects who complete the screening examinations and assessments will proceed to the treatment period.
Treatment Period: Subjects who pass screening will enter the neoadjuvant therapy phase, receiving treatment with HRS-4642 in combination with Nimotuzumab and the AG regimen. The predefined administration regimen is as follows:
HRS-4642: 500 mg intravenous infusion on Day 1, and 1200 mg intravenous infusion on Day 8, every 3 weeks per cycle.
Nimotuzumab: 400 mg intravenous infusion on Days 1 and 8, every 3 weeks per cycle.
Albumin-bound paclitaxel: 125 mg/m² intravenous infusion on Days 1 and 8, every 3 weeks per cycle.
Gemcitabine: 1000 mg/m² intravenous infusion on Days 1 and 8, every 3 weeks per cycle.
Neoadjuvant therapy will consist of 4 cycles. After completing 2 cycles and 4 cycles of neoadjuvant therapy, subjects will undergo radiographic imaging for efficacy evaluation. After completing 4 cycles of neoadjuvant therapy, eligibility for radical surgery will be assessed by a Multidisciplinary Team (MDT). If assessed as eligible for radical surgery, the subject will undergo surgery within 4 weeks after completing neoadjuvant therapy.
After surgery, subjects will enter the adjuvant therapy phase. Adjuvant therapy should begin within 4 to 12 weeks after surgery. The recommended adjuvant treatment regimen is to continue HRS-4642 + Nimotuzumab + AG for 4 cycles. If a subject cannot receive HRS-4642 + Nimotuzumab + AG as adjuvant therapy, the investigator will develop an adjuvant treatment plan based on a comprehensive assessment. The adjuvant therapy phase shall not exceed 4 cycles.
If the assessment determines that radical surgery is not possible, and the subject has not experienced disease progression, the subject may continue to receive study treatment if the investigator assesses that continued treatment is likely to be beneficial.
Subjects will receive HRS-4642 in combination with Nimotuzumab and AG until radiographic disease progression, unacceptable toxicity, voluntary withdrawal, loss to follow-up/death occurs (whichever comes first).
During the treatment period, subject visits will occur on Day 1 and Day 8 of each cycle, and on Cycle 1 Day 15. Tumor imaging assessments will be performed at Cycle 3 Day 1 (±7 days) and Cycle 4 Day 21 (±7 days) (upon completion of neoadjuvant therapy). For subjects who undergo radical surgery, assessments will be performed every 12 weeks (±7 days) postoperatively. For subjects who do not undergo radical surgery, subsequent assessments will be performed every 6 weeks (±7 days) until radiographic disease progression, initiation of new anti-tumor therapy, voluntary withdrawal, loss to follow-up/death occurs (whichever comes first). If clinically indicated, imaging examinations and assessments may be performed at any time. All subjects must undergo the corresponding examinations and imaging assessments at the end-of-treatment visit (if more than 4 weeks have passed since the last assessment).
Follow-up Period: After discontinuing study treatment, subjects must return to the research center for a safety follow-up visit 30 days (±7 days) after the last dose or before starting new anti-tumor therapy. Subjects will enter the survival follow-up period after the last dose of study treatment. The investigator must conduct survival follow-ups every 2 months (±7 days) until the subject dies, is lost to follow-up, the investigator terminates the study, or other study termination criteria are met (whichever comes first). For subjects who discontinue the study for reasons other than radiographic disease progression, tumor progression follow-up should continue, including radiographic assessments per the protocol-specified frequency, until disease progression, initiation of new anti-tumor therapy, etc.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: