HRS-4642 plus AG vs AG alone in first-line advanced pancreatic cancer with KRAS G12D mutation
Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Study of HRS-4642 Combined With Chemotherapy Versus Chemotherapy Alone as First-line Treatment for Advanced or Metastatic Pancreatic Adenocarcinoma Harboring KRAS G12D Mutation
Run by Jiangsu HengRui Medicine Co., Ltd. · NCT07232875 · Data updated 2026-11-12
This trial tests whether adding HRS-4642 to AG therapy helps people with KRAS G12D‑mutant advanced or metastatic pancreatic cancer in their first-line treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 588 (estimated) |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | November 21, 2025 |
| Main results expected | April 2029 |
| Study ends | April 2029 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07232875 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with KRAS G12D-mutant advanced or metastatic pancreatic cancer seeking first-line therapy, good performance status (ECOG 0–1), measurable disease, and able to consent.
✕Probably not a fit
Patients with low performance status, non-measurable disease, or significant comorbidities may not benefit and could be at higher risk from treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 trial randomizes adults with KRAS G12D-mutant advanced or metastatic pancreatic cancer to receive either HRS-4642 plus AG or AG with placebo. Participants must have good performance status, measurable disease, and adequate organ function, and must be willing to provide informed consent. The primary comparison assesses whether adding HRS-4642 improves outcomes over AG alone in the first-line setting, with safety monitoring throughout treatment. Enrollment is conducted at Renji Hospital and Shanghai Jiao Tong University School of Medicine in Shanghai, led by Jiangsu HengRui Medicine Co., Ltd.
Why it matters
Potential benefit: If successful, the regimen could offer improved disease control or survival for patients with this KRAS G12D-mutant cancer.
How similar studies have gone: Previous studies in similar targeted-therapy plus standard regimens have shown mixed results; this trial tests a specific KRAS G12D–focused approach in first-line pancreatic cancer.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Age 18-75 years old (inclusive) at the time of signing the informed consent form 3. Male or female 4. ECOG score of 0 or 1 5. Expected survival ≥ 12 weeks 6. At least one measurable lesion according to RECIST v1.1 criteria Exclusion Criteria: 1. Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study 2. Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures 3. Known hypersensitivity to any component of HRS-4642; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination 4. Received other major surgery other than diagnosis or biopsy within 28 days before the first dose; Minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7 days prior to the first dose; Presence of non-healing wounds (severe, non-healing, or dehiscence), untreated fractures 5. Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or who have 5 half-lives of this investigational drug, whichever is shorter 6. Use of a live attenuated vaccine within 28 days prior to the first dose of study medication, or anticipated need for a live attenuated vaccine during study treatment 7. Have a history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation 8. Those who have active pulmonary tuberculosis infection within 1 year before enrollment, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not been formally treated 9. Active hepatitis B 10. Presence of clinically significant acute or chronic pancreatitis 11. Poorly controlled or severe cardiovascular and cerebrovascular diseases, arterior/venous thrombotic events within 6 months prior to study entry 12. Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the start of study treatment, but screening can be performed if surgical treatment has been performed and the obstruction has been completely resolved
Where it's running
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Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Hongxia Han
- Email: hongxia.han@hengrui.com
- Phone: +0518-81220121
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.