Actively Recruiting
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
Led by Zhejiang University · Updated on 2026-06-03
133
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying advanced pancreatic cancer patients with a specific KRAS G12D mutation to evaluate the effectiveness of a treatment combining HRS-4642 with nimotuzumab and chemotherapy. This phase II clinical study includes patients with metastatic or locally advanced pancreatic cancer and aims to assess the response rate and survival outcomes. The study uses a Simon two-stage design to evaluate safety and efficacy early and decide on further enrollment. Participants receive HRS-4642, an intravenous KRAS G12D inhibitor, combined with nimotuzumab, a monoclonal antibody targeting EGFR, and the AG chemotherapy regimen (albumin paclitaxel and gemcitabine) given every three weeks. The first stage enrolls 10-15 patients to assess safety and remission rates, followed by a randomized second stage comparing two cohorts receiving different combinations of these treatments. Treatment continues until disease progression or unacceptable toxicity. Throughout the study, patients undergo screening, treatment, and follow-up periods including safety and survival monitoring after treatment ends. Researchers measure objective response rate as the primary outcome up to two years, along with remission duration, disease control rate, progression-free survival, and overall survival. Vital organ functions and other health parameters are regularly assessed to monitor tolerance and treatment effects during the trial.
CONDITIONS
Brief Title
HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Metastatic pancreatic cancer for Arm A or locally advanced pancreatic cancer for Arm B
- Tumor tissue contains KRAS G12D mutation
- No prior systemic antitumor therapy in advanced stage; if prior neoadjuvant or adjuvant therapy, last treatment was over 6 months ago
- At least one measurable lesion according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Expected survival period of at least 3 months
- Adequate vital organ function including neutrophil count, platelets, hemoglobin, serum albumin, liver enzymes, creatinine clearance, urinary protein, ECG, and heart function
- Women of childbearing age must have a negative pregnancy test, not be lactating, and agree to contraception during and for 6 months after treatment; men must agree to contraception or surgical sterilization
- Willingness to participate and sign informed consent, with good compliance
You will not qualify if you...
- Previous targeted therapy against KRAS G12D or EGFR
- Major surgery or trauma within 4 weeks before enrollment, or palliative local treatment within 2 weeks
- Participation in other clinical trial medications within 4 weeks, except observational or follow-up studies
- Use of drugs that strongly affect liver enzymes CYP3A4 or CYP2C8 within 14 days
- Presence of central nervous system metastases
- Acute or chronic pancreatitis requiring treatment
- Gastrointestinal obstruction within 6 months unless fully resolved by surgery
- Unstable third space effusions requiring intervention within 2 weeks
- Severe infection or fever of unknown cause within 4 weeks
- Severe cardiovascular or cerebrovascular disease
- Known or suspected interstitial pneumonia except minor imaging changes
- History of neurological or psychiatric disorders including epilepsy or dementia
- Non-healing wounds or fractures
- Unresolved adverse events from prior treatment except alopecia
- Other malignant tumors within 5 years except low-risk treated cancers
- Active hepatitis B or C, HIV, active syphilis, or active tuberculosis within 48 weeks
- Allergies to any study drugs or components
- Other factors that may affect study results or lead to study termination as judged by investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or toxicity intolerance
Participants receive HRS-4642 combined with Nimotuzumab and chemotherapy (gemcitabine plus nab-paclitaxel) as first-line treatment for advanced pancreatic cancer until disease progression or unacceptable toxicity.
Treatment cycles every 3 weeks with infusions on Day 1 and Day 8 of each cycle
Duration - Up to 2 years
Participants are followed for safety and survival after completion of study treatment.
Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
2
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Tingbo Liang, MD
Y
Yiwen Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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