Advanced Breast CancerPhase 1NCT06710990
Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer
A Phase 1 study testing SHR-A1811, Ritonavir and Itraconazole in people with Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- SHR-A1811, Ritonavir and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesChina
- Study dates
- 17 Feb 2025to 15 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG score of 0 or 1;
- Expected survival of not less than 3 months;
- Important organ functions meet the following criteria:
- Absolute neutrophil count (ANC) ≥1.5×109/L (1,500/mm3);
- Platelet count (PLT) ≥100×109/L (100,000/mm3);
- Hemoglobin (Hgb) ≥9.0 g/dL (90g/L);
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- Albumin level ≥3.0 g/dL;
- Total serum bilirubin ≤1.5× the upper limit of normal (ULN);
- Prothrombin time and activated partial thromboplastin time (aPTT) ≤1.5×ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastasis, ALT and AST ≤5×ULN);
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min;
- QTcF ≤470 msec;
- Left ventricular ejection fraction (LVEF) ≥50%.
Who cannot join
- Known active central nervous system metastases that have not been treated with surgery or radiation, except those that have been stable for at least 1 month after treatment and have discontinued corticosteroids for >2 weeks;
- Having cardiac diseases, such as severe/unstable angina, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months before the first administration, etc.
- Known severe allergic history to any component of the SHR-A1811 product (ADC, total antibody, unconjugated toxin SHR169265 or its excipients), or hypersensitivity to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.);
- Having contraindications to ritonavir or itraconazole use;
- Having one or more factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, partial or total gastrectomy, etc.), or having active gastrointestinal diseases or other diseases that may significantly affect drug absorption, distribution, metabolism, or excretion.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan Cancer Hospital
Changsha, Hunan, 410013
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510200
About this study
Official title: A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer
The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- SHR-A1811, Ritonavir, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811
RitonavirDrug
Ritonavir
ItraconazoleDrug
Itraconazole
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: SHR-A1811 + Ritonavir | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Ritonavir |
| Cohort 2: SHR-A1811 + Itraconazole | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum concentration (Cmax) for SHR-A1811
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
The maximum concentration (Cmax) for payload
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
Area under the concentration curve from time 0 to 16 days (AUC0-16d) for SHR-A1811
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
Area under the concentration curve from time 0 to 16 days (AUC0-16d) for payload
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
Secondary outcomes (6)
Time to maximum plasma concentration (Tmax)
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
Terminal half-life (t1/2)
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
Area under the concentration curve from time 0 to infinity (AUCinf)
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
Clearance (CL)
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
Volume of distribution at steady state (Vss)
Measured: Cycle 2 and Cycle 3. Each cycle is 21 days.
Incidence and severity of adverse events
Measured: From the beginning of screening period to approximately 3 months after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start17 Feb 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
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
- NCT06710990
- Sponsor's protocol ID
- SHR-A1811-105
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2024
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06710990
- Acronym / sponsor ID
- SHR-A1811-105
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 2 Dec 2024 (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.
The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: SHR-A1811 + Ritonavir | Experimental | Drug: SHR-A1811, Drug: Ritonavir |
| Cohort 2: SHR-A1811 + Itraconazole | Experimental | Drug: SHR-A1811, Drug: Itraconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ECOG score of 0 or 1;
- Expected survival of not less than 3 months;
- Important organ functions meet the following criteria:
Key exclusion criteria (5 listed)
- Known active central nervous system metastases that have not been treated with surgery or radiation, except those that have been stable for at least 1 month after treatment and have discontinued corticosteroids for >2 weeks;
- Having cardiac diseases, such as severe/unstable angina, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months before the first administration, etc.
- Known severe allergic history to any component of the SHR-A1811 product (ADC, total antibody, unconjugated toxin SHR169265 or its excipients), or hypersensitivity to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.);
- Having contraindications to ritonavir or itraconazole use;
- Having one or more factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, partial or total gastrectomy, etc.), or having active gastrointestinal diseases or other diseases that may significantly affect drug absorption, distribution, metabolism, or excretion.
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 |
|---|---|---|
| SHR-A1811SHR-A1811 | Drug | Cohort 1: SHR-A1811 + Ritonavir, Cohort 2: SHR-A1811 + Itraconazole |
| RitonavirRitonavir | Drug | Cohort 1: SHR-A1811 + Ritonavir |
| ItraconazoleItraconazole | Drug | Cohort 2: SHR-A1811 + Itraconazole |
Primary outcome
The maximum concentration (Cmax) for SHR-A1811
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
The maximum concentration (Cmax) for payload
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
Area under the concentration curve from time 0 to 16 days (AUC0-16d) for SHR-A1811
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
Area under the concentration curve from time 0 to 16 days (AUC0-16d) for payload
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
6 secondary outcomes
Time to maximum plasma concentration (Tmax)
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
Terminal half-life (t1/2)
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
Area under the concentration curve from time 0 to infinity (AUCinf)
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
Clearance (CL)
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
Volume of distribution at steady state (Vss)
Time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.
Incidence and severity of adverse events
Time frame: From the beginning of screening period to approximately 3 months after the last dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-A1811, Ritonavir and Itraconazole in people with Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 13 inclusion and 5 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: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum concentration (Cmax) for SHR-A1811 (time frame: Cycle 2 and Cycle 3. Each cycle is 21 days.). The study lists 4 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 4 Jun 2026.