Can a new drug combo outsmart RAS-Mutated pancreatic cancer?
NCT ID NCT07806058
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether an experimental drug called HRS-7172, when combined with other antitumor therapies, can safely shrink or control advanced pancreatic cancer that has RAS mutations or amplifications. The study includes adults aged 18 to 70 with locally advanced or metastatic disease. Researchers will evaluate the treatment's safety, tolerability, and effectiveness, measuring outcomes like tumor response and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-7172 combined with other antitumor drugs (AG, SHR-1316, HRS-4642)
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced pancreatic cancer with RAS mutations, potentially slowing tumor growth and extending survival.
- What could go wrong
- This is an early-phase trial, so the treatment may not be effective or safe in all patients. Side effects are possible, and more research is needed before it could become a standard therapy.
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 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 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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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 to 70 years
- 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: 1. Capable of giving informed consent, have signed and dated the IRB/EC-approved informed consent form, and are willing and able to comply with scheduled visits, examination requirements, and other study procedures. 2. Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of sex. 3. ECOG performance status of 0 or 1. 4. Locally advanced or metastatic pancreatic cancer confirmed by histology and cytology, with RAS mutation/amplification detected by tissue or blood genetic testing. 5. Participants who have received at most one prior line of standard therapy. 6. Life expectancy ≥ 12 weeks. 7. At least one measurable lesion as defined by RECIST v1.1. 8. Participants must provide formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimens. 9. Adequate organ and bone marrow function. 10. Female participants of childbearing potential must agree to use contraception and refrain from donating eggs from the time of signing the informed consent form until 6 months after the last dose of the study drug; serum human chorionic gonadotropin (HCG) test must be negative within 7 days prior to the first dose, and must not be breastfeeding. Male participants whose partners are women of childbearing potential must agree to use contraception and refrain from donating sperm from the time of signing the informed consent form until 5 months after the last dose of the study drug. Exclusion Criteria: 1. Participants with untreated or active central nervous system (CNS) metastases or leptomeningeal metastases (including history thereof). 2. Concurrent other malignancies ≤ 3 years prior to the first dose, with the following exceptions: adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin carcinoma, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid carcinoma after radical surgery (hormonal therapy for non-metastatic prostate cancer or breast cancer is permitted). 3. Participants with uncontrollable tumor-related pain as determined by the investigator. Participants requiring analgesic therapy must have a stable analgesic regimen at study entry; symptomatic lesions eligible for palliative radiotherapy should have completed treatment before study entry. 4. Severe cardiovascular or cerebrovascular diseases. 5. Gastrointestinal diseases affecting drug administration/absorption, including but not limited to dysphagia, malabsorption syndrome, refractory nausea, vomiting, diarrhea, Crohn's disease, and ulcerative colitis; intestinal obstruction or related symptoms and signs within 6 months prior to the start of study treatment, unless surgically treated with complete resolution; clinically significant acute or chronic pancreatitis; other gastrointestinal conditions deemed unsuitable for enrollment by the investigator. 6. Clinically significant bleeding events (including but not limited to hematemesis, melena, hematochezia, etc., excluding hemorrhoidal bleeding or isolated fecal occult blood positive) within 6 months prior to the start of study treatment, or a definite bleeding tendency, high bleeding risk, coagulation disorder, or thrombotic tendency. 7. Clinically symptomatic moderate or severe ascites (i.e., requiring therapeutic paracentesis or drainage within 2 weeks prior to the start of study treatment; participants with only small-volume ascites on imaging without clinical symptoms may be enrolled); uncontrolled or moderate or greater pleural effusion or pericardial effusion. 8. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization; active infection of CTCAE ≥ Grade 2 requiring systemic antibiotic therapy within 2 weeks prior to the first dose; excluding participants receiving prophylactic antibiotic therapy (e.g., for prevention of urinary tract infection). 9. History of immunodeficiency, including HIV positive; active hepatitis B (positive HBsAg at screening with HBV DNA quantification ≥ 1000 copies/mL or 500 IU/mL) or hepatitis C (anti-HCV positive with HCV RNA positive). 10. Active pulmonary tuberculosis infection within 1 year prior to enrollment as determined by history or imaging, or a history of active pulmonary tuberculosis infection more than 1 year ago without standard treatment. 11. Adverse reactions from prior antitumor therapy that have not recovered to CTCAE ≤ Grade 1 (except alopecia, Grade 2 peripheral neurotoxicity, laboratory values meeting enrollment criteria, or other conditions determined by the investigator not to affect study drug treatment). 12. Systemic antitumor therapy (including chemotherapy, biological therapy, targeted therapy, immunotherapy, radical radiotherapy, etc.) within 4 weeks prior to the start of study treatment. 13. Major organ surgery (excluding needle biopsy), significant trauma within 4 weeks prior to the first dose of study drug, or planned elective surgery during the study; minor traumatic procedures (biopsy, endoscopy, and drainage) within 7 days prior to the first dose. 14. Receipt of live attenuated vaccines within 28 days prior to the first dose of study drug, or anticipated need for live attenuated vaccines during the study treatment period. 15. Pregnant or lactating women, or female participants planning to become pregnant during the study period or within 7 months after the last dose of study drug. 16. History of severe allergic reactions to any component of any study drug to be received, or to other monoclonal antibodies. 17. Participants judged by the investigator to have other factors that may affect study results or lead to premature study termination, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, severely abnormal laboratory values, family or social factors, and other circumstances that may affect participant safety or the collection of study data.
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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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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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Other studies related to the condition(s) this trial covers.
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