HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation

NCT07240766 | Recruiting Phase 2

• 1 other identifier: CAPT05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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).

Conditions

Borderline Resectable Pancreatic Adenocarcinoma

Keywords

pancreatic adenocarcinoma; borderline resectable; KRAS G12D mutation

Outcome Measures

Primary Outcomes (1)

• 12-month Event-Free Survival (EFS) rate

  The proportion of patients who had tumor progression, tumor recurrence (local, regional or distant) or death within 1 year after surgery, whichever occurred first

  Up to one year

Secondary Outcomes (8)

• Event Free Survival, EFS

  Up to 2 years

• Surgical resection rate

  Up to 1 year

• R0 resection rate

  Up to 1 year

• Pathological Complete Response (pCR) Rate

  Up to 1 year

• Major Pathological Response (MPR) Rate

  Up to 1 year

Study Arms (1)

Treatment group

EXPERIMENTAL

Perioperative Treatment with HRS-4642 in Combination with Nimotuzumab and the AG Regimen

Drug: HRS-4642+AG+Nimotuzumab

Interventions

HRS-4642+AG+Nimotuzumab DRUG

HRS-4642 Injection: 500 mg intravenous infusion on Day 1, and 1200 mg intravenous infusion on Day 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Nimotuzumab: 400 mg on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Paclitaxel for Injection (Albumin-bound): 125 mg/m² on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Gemcitabine: 1000 mg/m² on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. The recommended adjuvant treatment regimen is to continue HRS-4642 + Nimotuzumab + AG for 4 cycles.

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years (inclusive).
• Histopathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium).
• Radiologically confirmed borderline resectable pancreatic cancer (according to the latest NCCN guidelines definition), with no distant metastases.
• Tumor tissue testing confirms KRAS G12D mutation.
• No prior systemic anti-tumor therapy.
• At least one evaluable lesion according to RECIST v1.1 criteria.
• ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
• Expected survival time ≥ 3 months.
• Adequate organ function meeting the following requirements (no use of any blood components or colony-stimulating factors within 2 weeks prior to enrollment):
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
• Platelets ≥ 80 × 10⁹/L
• Hemoglobin ≥ 100 g/L
• Serum albumin ≥ 30 g/L
• Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN and ALP ≤ 2.5 × ULN
• Creatinine clearance ≥ 50 mL/min or Serum creatinine ≤ 1.5 × ULN (Calculation formula see section 13.3)

You may not qualify if:

• \. Prior Treatment:
• Major surgical procedure or significant traumatic injury within 4 weeks prior to enrollment, or palliative local therapy (including but not limited to palliative radiotherapy, interventional therapy) within 2 weeks prior to enrollment.
• Treatment with any investigational drug from another clinical study within 4 weeks prior to enrollment, except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
• Use of strong inhibitors or inducers of hepatic drug-metabolizing enzymes CYP3A4 or CYP2C8 within 14 days prior to enrollment.
• \. Acute or chronic pancreatitis requiring clinical intervention.
• \. History or presence of symptoms/signs of gastrointestinal obstruction within 6 months prior to the start of study treatment. Subjects may be screened if they have undergone surgical procedure resulting in complete resolution of the obstruction.
• \. Third-space fluid accumulation (e.g., significant pleural effusion, ascites, etc.) that is unstable (unable to remain stable without intervention after drainage removal) within 2 weeks prior to enrollment. Subjects with only small amounts of fluid visible on imaging and without clinical symptoms may be enrolled.
• \. Severe infection within 4 weeks prior to enrollment, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; Unexplained fever \>38.5°C within 2 weeks prior to enrollment (subjects with fever judged by the investigator to be due to the tumor may be enrolled); Presence of signs/symptoms of infection requiring intravenous antibiotic therapy within 2 weeks prior to enrollment (excluding prophylactic antibiotic use).
• \. Severe cardiovascular and cerebrovascular diseases:
• Important arterial/venous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis (excluding muscular venous thrombosis not requiring anticoagulation), and pulmonary embolism.
• Poorly controlled cardiac symptoms or diseases, such as:
• Myocardial infarction within 6 months.
• Unstable angina.
• Heart failure of NYHA class II or above.
• Subjects with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (2)

First Affiliated Hospital of Zhejiang University Schlool of Medicine

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

the First Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Central Study Contacts

Tingbo Liang, MD

CONTACT

86+19941463683; liangtingbo@zju.edu.cn

Yiwen Chen, MD

CONTACT

86+15088682641; yiwenchen0705@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital President

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 21, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): November 15, 2028
• Last Updated: February 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)