Can a Pan-RAS inhibitor outsmart pancreatic cancer?
NCT ID NCT07736612
First seen Jul 30, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This trial is testing whether a new oral drug called HRS-2329, which blocks multiple RAS proteins, can shrink tumors or slow disease when combined with other anti-cancer therapies. It is enrolling adults with advanced pancreatic cancer that has RAS mutations or amplifications and has not responded to prior treatment. The study aims to see if the combination is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a pan-RAS inhibitor called HRS-2329, taken as a tablet
- What this could lead to
- If successful, this could point toward a new treatment option for advanced pancreatic cancer, especially for tumors with hard-to-treat RAS mutations.
- What could go wrong
- This is an early-phase trial, so the drug may not work or could cause unexpected side effects. The combination approach also adds complexity and risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years. * Histopathologically confirmed locally advanced or metastatic pancreatic adenocarcinoma (originating from pancreatic ductal epithelium) that is not amenable to curative therapy. * RAS mutation or amplification detected in tumor tissue or blood (by RAS testing). * Prior anti-tumor therapy: 1. For cohort HRS-2329-A: at least one line of standard systemic therapy in the advanced setting; 2. For cohorts HRS-2329-B and HRS-2329-C: at most one line of standard systemic therapy in the advanced setting. * At least one measurable lesion according to RECIST version 1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. * Life expectancy ≥ 3 months. * Adequate function of vital organs. * Use of appropriate contraceptive methods during the study period, and so forth. * Voluntary participation in this study with signed informed consent, good compliance, and willingness to cooperate with follow-up assessments. Exclusion Criteria: * Prior treatment with drugs similar to the investigational product. * Known presence of central nervous system (CNS) metastases. * Acute or chronic pancreatitis requiring clinical intervention. * Gastrointestinal disorders that may affect drug administration/absorption, including but not limited to dysphagia, malabsorption syndrome, refractory nausea, vomiting, or diarrhea, Crohn's disease, and ulcerative colitis. * Gastrointestinal obstruction, or signs/symptoms of gastrointestinal obstruction; however, patients who have undergone surgical intervention with complete resolution of the obstruction may be considered for screening. * Concurrent biliary obstruction with risk of biliary tract infection (patients with treatable biliary obstruction may be enrolled if adequate biliary drainage is achieved and the risk of biliary infection is resolved after treatment). * Third-space fluid collections (e.g., massive pleural effusion, ascites) that cannot be stabilised (i.e., no intervention required after drainage removal) within 2 weeks prior to enrolment; patients with only a small amount of fluid detected by imaging and without clinical symptoms may be enrolled. * Severe infection within 4 weeks prior to enrolment, such as severe pneumonia, bacteraemia, or infectious complications requiring hospitalisation; unexplained fever \>38.5°C within 2 weeks prior to enrolment ; signs/symptoms of infection requiring intravenous antibiotic therapy within 2 weeks prior to enrolment. * Severe cardiovascular or cerebrovascular diseases. * Known or suspected interstitial lung disease (isolated imaging findings of interstitial changes are not excluded). * History of definite neurological or psychiatric disorders, including epilepsy and dementia. * Non-healing wounds (severe, non-healing, or dehiscent), or unhealed fractures. * Adverse events from prior therapy not recovered to NCI-CTCAE Grade ≤1 at enrolment . * History of malignancies other than the primary tumour within 5 years prior to enrolment, with the exception of malignancies with low risk of metastasis and death, such as adequately treated carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin. * Active hepatitis B infection. * For Cohort C, conditions that are unsuitable for immunotherapy. * Known allergy to any component of any of the study drugs to be administered. * Any other condition that, in the investigator's judgement, may affect the study results or result in premature termination of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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the First Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China
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