Pancreatic CancerPhase 1/2NCT07806058
An Open-Label, Multicenter, Phase IB/II Clinical Study of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors
A Phase 1/2 study testing HRS-7172 + AG + SHR-1316, HRS-7172 + AG + SHR-1316; and HRS-7172 + AG; in people with Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a Phase IB/II clinical trial designed to evaluate HRS-7172 in combination with antitumor drugs in participants with advanced pancreatic cancer harboring RAS mutations or amplifications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- HRS-7172 + AG + SHR-1316, HRS-7172 + AG + SHR-1316; and HRS-7172 + AG;
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of sex.
- ECOG performance status of 0 or 1.
- Locally advanced or metastatic pancreatic cancer confirmed by histology and cytology, with RAS mutation/amplification detected by tissue or blood genetic testing.
- Participants who have received at most one prior line of standard therapy.
- Life expectancy ≥ 12 weeks.
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- At least one measurable lesion as defined by RECIST v1.1.
- Participants must provide formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimens.
- Adequate organ and bone marrow function.
- 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.
Who cannot join
- Participants with untreated or active central nervous system (CNS) metastases or leptomeningeal metastases (including history thereof).
- 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).
- 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.
- Severe cardiovascular or cerebrovascular diseases.
- 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.
- 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.
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- 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.
- 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).
- 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).
- 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.
- 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).
- Systemic antitumor therapy (including chemotherapy, biological therapy, targeted therapy, immunotherapy, radical radiotherapy, etc.) within 4 weeks prior to the start of study treatment.
- 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.
- 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.
- 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.
- History of severe allergic reactions to any component of any study drug to be received, or to other monoclonal antibodies.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ning/Yirong Dou/Cheng, PhD/MD contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu
About this study
Official title: An Open-Label, Multicenter, Phase IB/II Clinical Study of the Safety, Tolerability, and Efficacy of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors
This is a Phase IB/II clinical trial designed to evaluate HRS-7172 in combination with antitumor drugs in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.
The study process includes a screening period (from signed informed consent to first dose), a treatment period (from first dose to last dose), and a follow-up period (safety and survival follow-up after last dose). A Safety Monitoring Committee (SMC), composed of the principal investigator and sponsor representatives, will be established during the study to review the safety and efficacy data generated. The SMC will make decisions on study-related matters, including but not limited to combination regimen dose exploration, combination regimen selection, efficacy expansion cohort selection, expansion initiation timing, and recommended dose for expansion (RDE).
This study aims to evaluate the safety, tolerability, and efficacy of HRS-7172 in combination with other antitumor therapies in participants with advanced or metastatic pancreatic cancer harboring RAS mutations or amplifications.
- Conditions
- Pancreatic Cancer
- Being tested
- HRS-7172 + AG + SHR-1316, HRS-7172 + AG + SHR-1316;, HRS-7172 + AG;, HRS-717 + HRS-4642+SHR-1316;, HRS-717 + HRS-4642;
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7172 + AG + SHR-1316Drug
HRS-7172 + AG + SHR-1316; low dose
HRS-7172 + AG + SHR-1316;Drug
HRS-7172 + AG + SHR-1316; high dose
HRS-7172 + AG;Drug
HRS-7172 + AG; low/high dose
HRS-7172 + AG + SHR-1316;Drug
HRS-7172 + AG + SHR-1316; low/high dose
HRS-717 + HRS-4642+SHR-1316;Drug
HRS-717 + HRS-4642+SHR-1316; low dose
HRS-717 + HRS-4642+SHR-1316;Drug
HRS-717 + HRS-4642+SHR-1316; high dose
HRS-717 + HRS-4642;Drug
HRS-717 + HRS-4642; low/high dose
HRS-717 + HRS-4642+SHR-1316;Drug
HRS-717 + HRS-4642+SHR-1316; low/high dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A-low dose: HRS-7172 + AG + SHR-1316 | Experimental | Not described Receives: Drug: HRS-7172 + AG + SHR-1316 |
| Treatment group A-high dose: HRS-7172 + AG + SHR-1316 | Experimental | Not described Receives: Drug: HRS-7172 + AG + SHR-1316; |
| Treatment group A1: HRS-7172 + AG | Experimental | Not described Receives: Drug: HRS-7172 + AG; |
| Treatment group A2: HRS-7172 + AG + SHR-1316 | Experimental | Not described Receives: Drug: HRS-7172 + AG + SHR-1316; |
| Treatment group B-low dose: HRS-717 + HRS-4642+SHR-1316 | Experimental | Not described Receives: Drug: HRS-717 + HRS-4642+SHR-1316; |
| Treatment group B-high dose: HRS-717 + HRS-4642+SHR-1316 | Experimental | Not described Receives: Drug: HRS-717 + HRS-4642+SHR-1316; |
| Treatment group B1: HRS-717 + HRS-4642 | Experimental | Not described Receives: Drug: HRS-717 + HRS-4642; |
| Treatment group B2: HRS-717 + HRS-4642+SHR-1316 | Experimental | Not described Receives: Drug: HRS-717 + HRS-4642+SHR-1316; |
What is being measured
The primary outcome is the main question the study is designed to answer.
RDE in advanced pancreatic cancer with RAS mutation or amplification
Measured: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Incidence and severity of adverse events (AEs) (per NCI-CTCAE V6.0 criteria)
Measured: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
ORR assessed by the investigator
Measured: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Secondary outcomes (7)
Objective Response Rate (ORR) as assessed by the investigator
Measured: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Disease Control Rate (DCR) as assessed by the investigator
Measured: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Duration of Response (DoR) as assessed by the investigator
Measured: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Progression-Free Survival (PFS) as assessed by the investigator
Measured: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Overall Survival (OS)
Measured: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Anti-Drug Antibodies (ADA)
Measured: From pre-dose on C1D1 to 30 days after the last dose. Estimated to be 2 years
Incidence and severity of AEs
Measured: From the participant's signing of the informed consent form to the end of the safety follow-up period. Estimated to be 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Oct 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be divided into two parts based on participants' RAS mutation types: Part A and Part B. Both Part A and Part B include a Phase IB stage and a Phase II stage. In the Phase IB stage, dose escalation will be conducted with two pre-specified dose levels. After completing the Phase IB dose escalation stage, the study will proceed to the Phase II efficacy expansion stage, with participants randomized 1:1 into A1/A2 or B1/B2.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806058
- Sponsor's protocol ID
- HRS-7172-201
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase IB/II Clinical Study of the Safety, Tolerability, and Efficacy of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors
- ClinicalTrials.gov ID
- NCT07806058
- Acronym / sponsor ID
- HRS-7172-201
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IB/II clinical trial designed to evaluate HRS-7172 in combination with antitumor drugs in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.
The study process includes a screening period (from signed informed consent to first dose), a treatment period (from first dose to last dose), and a follow-up period (safety and survival follow-up after last dose). A Safety Monitoring Committee (SMC), composed of the principal investigator and sponsor representatives, will be established during the study to review the safety and efficacy data generated. The SMC will make decisions on study-related matters, including but not limited to combination regimen dose exploration, combination regimen selection, efficacy expansion cohort selection, expansion initiation timing, and recommended dose for expansion (RDE).
This study aims to evaluate the safety, tolerability, and efficacy of HRS-7172 in combination with other antitumor therapies in participants with advanced or metastatic pancreatic cancer harboring RAS mutations or amplifications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- The study will be divided into two parts based on participants' RAS mutation types: Part A and Part B. Both Part A and Part B include a Phase IB stage and a Phase II stage. In the Phase IB stage, dose escalation will be conducted with two pre-specified dose levels. After completing the Phase IB dose escalation stage, the study will proceed to the Phase II efficacy expansion stage, with participants randomized 1:1 into A1/A2 or B1/B2.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A-low dose: HRS-7172 + AG + SHR-1316 | Experimental | Drug: HRS-7172 + AG + SHR-1316 |
| Treatment group A-high dose: HRS-7172 + AG + SHR-1316 | Experimental | Drug: HRS-7172 + AG + SHR-1316; |
| Treatment group A1: HRS-7172 + AG | Experimental | Drug: HRS-7172 + AG; |
| Treatment group A2: HRS-7172 + AG + SHR-1316 | Experimental | Drug: HRS-7172 + AG + SHR-1316; |
| Treatment group B-low dose: HRS-717 + HRS-4642+SHR-1316 | Experimental | Drug: HRS-717 + HRS-4642+SHR-1316; |
| Treatment group B-high dose: HRS-717 + HRS-4642+SHR-1316 | Experimental | Drug: HRS-717 + HRS-4642+SHR-1316; |
| Treatment group B1: HRS-717 + HRS-4642 | Experimental | Drug: HRS-717 + HRS-4642; |
| Treatment group B2: HRS-717 + HRS-4642+SHR-1316 | Experimental | Drug: HRS-717 + HRS-4642+SHR-1316; |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of sex.
- ECOG performance status of 0 or 1.
- Locally advanced or metastatic pancreatic cancer confirmed by histology and cytology, with RAS mutation/amplification detected by tissue or blood genetic testing.
- Participants who have received at most one prior line of standard therapy.
Key exclusion criteria (17 listed)
- Participants with untreated or active central nervous system (CNS) metastases or leptomeningeal metastases (including history thereof).
- 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).
- 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.
- Severe cardiovascular or cerebrovascular diseases.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7172 + AG + SHR-1316HRS-7172 + AG + SHR-1316; low dose | Drug | Treatment group A-low dose: HRS-7172 + AG + SHR-1316 |
| HRS-7172 + AG + SHR-1316;HRS-7172 + AG + SHR-1316; high dose | Drug | Treatment group A-high dose: HRS-7172 + AG + SHR-1316 |
| HRS-7172 + AG;HRS-7172 + AG; low/high dose | Drug | Treatment group A1: HRS-7172 + AG |
| HRS-7172 + AG + SHR-1316;HRS-7172 + AG + SHR-1316; low/high dose | Drug | Treatment group A2: HRS-7172 + AG + SHR-1316 |
| HRS-717 + HRS-4642+SHR-1316;HRS-717 + HRS-4642+SHR-1316; low dose | Drug | Treatment group B-low dose: HRS-717 + HRS-4642+SHR-1316 |
| HRS-717 + HRS-4642+SHR-1316;HRS-717 + HRS-4642+SHR-1316; high dose | Drug | Treatment group B-high dose: HRS-717 + HRS-4642+SHR-1316 |
| HRS-717 + HRS-4642;HRS-717 + HRS-4642; low/high dose | Drug | Treatment group B1: HRS-717 + HRS-4642 |
| HRS-717 + HRS-4642+SHR-1316;HRS-717 + HRS-4642+SHR-1316; low/high dose | Drug | Treatment group B2: HRS-717 + HRS-4642+SHR-1316 |
Primary outcome
RDE in advanced pancreatic cancer with RAS mutation or amplification
Time frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Incidence and severity of adverse events (AEs) (per NCI-CTCAE V6.0 criteria)
Time frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
ORR assessed by the investigator
Time frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
7 secondary outcomes
Objective Response Rate (ORR) as assessed by the investigator
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Disease Control Rate (DCR) as assessed by the investigator
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Duration of Response (DoR) as assessed by the investigator
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Progression-Free Survival (PFS) as assessed by the investigator
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Overall Survival (OS)
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Anti-Drug Antibodies (ADA)
Time frame: From pre-dose on C1D1 to 30 days after the last dose. Estimated to be 2 years
Incidence and severity of AEs
Time frame: From the participant's signing of the informed consent form to the end of the safety follow-up period. Estimated to be 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning/Yirong Dou/Cheng, PhD/MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRS-7172 + AG + SHR-1316, HRS-7172 + AG + SHR-1316; and HRS-7172 + AG; in people with Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning/Yirong Dou/Cheng, PhD/MD (0518-82342973, ning.dou@hengrui.com/yirong.cheng.yc58@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RDE in advanced pancreatic cancer with RAS mutation or amplification (time frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.