Recurrent or Metastatic Solid TumorsNCT07387874
A Real-World Study of Trastuzumab Rezetecan in HER2+ Solid Tumors
An observational study of Recurrent or Metastatic Solid Tumors, run by Lixiaoling at 1 site in China.
Trial summary
To Observe and Evaluate the Safety Profile of Trastuzumab Rezetecan Alone or in Combination in Patients with HER-2 Protein-Expressing Recurrent or Metastatic Malignant Solid Tumors in a Real-World Setting. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Recurrent or Metastatic Solid Tumors
- What is being tested?
- Trastuzumab Rezetecan and Other Drugs
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to Jul 2028
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Based on investigator assessment, patients with HER-2 protein-expressing recurrent or metastatic malignant solid tumors are eligible to receive trastuzumab, either as monotherapy or in combination therapy.
Who may be able to join
- Sign the informed consent form voluntarily and agree to participate in this study.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Age ≥ 18 years.
- HER2 protein expression (including IHC 1+, IHC 2+, IHC 3+, or IHC 0 with ≤10% of invasive tumor cells showing incomplete/weak membrane staining). HER2 protein expression test results must be within 2 years.
- Patients with advanced solid tumors who have failed, are intolerant to, or refuse standard therapy, and are deemed by the investigator as suitable to receive Trastuzumab Rezetecan monotherapy or combination therapy.
Who cannot join
- Patients who are concurrently receiving other therapies of the same class.
- Patients currently enrolled in another interventional clinical study.
- Females with confirmed pregnancy or during lactation.
- Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trastuzumab Rezetecan Alone or in Combination for the Treatment of Patients With Recurrent or Metastatic Malignant Solid Tumors Expressing HER-2 Protein: A Single-Center, Real-World Study
To Observe and Evaluate the Safety Profile of Trastuzumab Rezetecan Alone or in Combination in Patients with HER-2 Protein-Expressing Recurrent or Metastatic Malignant Solid Tumors in a Real-World Setting.
Read the detailed description
Trastuzumab Rezetecan specifically binds to HER2 on the surface of tumor cells. The conjugate is subsequently internalized into the cells and transported to lysosomes, where the linker is cleaved by cathepsins to release the free toxin SHR169265. This payload inhibits the activity of DNA topoisomerase I, thereby inducing apoptosis in tumor cells. Owing to the high membrane permeability of SHR169265, a bystander killing effect is also observed: after being released inside tumor cells, it can diffuse into neighboring cells, exerting cytotoxic effects even on HER2-negative cells. This study aims to evaluate the efficacy and safety of Trastuzumab Rezetecan, either as monotherapy or in combination regimens, in patients with HER2-expressing recurrent or metastatic malignant solid tumors.
- Conditions
- Recurrent or Metastatic Solid Tumors
- Being tested
- Trastuzumab Rezetecan, Other Drugs
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab RezetecanDrug
Trastuzumab Rezetecan: 4.8 mg/kg, administered every 21 days as one treatment cycle. Patients will receive treatment according to the investigator-defined regimen containing Trastuzumab Rezetecan until disease progression (PD), intolerable toxicity, patient-initiated withdrawal, or the occurrence of other medical events determined by the physician that make the combination therapy unsuitable for continuation.
Other DrugsDrug
The administration regimens for Trastuzumab Rezetecan include, but are not limited to:
Combination with immune checkpoint inhibitors ± other agents Combination with targeted agents ± other agents Combination with radiotherapy ± other agents
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Trastuzumab Rezetecan: ± Other Drugs Receives: Drug: Trastuzumab Rezetecan; Drug: Other Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety （Incidence of Grade ≥3 AEs）
Safety （Incidence of Grade ≥3 AEs）
Measured: From the first dose on Day 1 through the last dose, for up to 3 years
Secondary outcomes (5)
ORR
Overall Response Rate
Measured: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months
PFS
Progression Free Survival
Measured: From the first vaccination to the first recorded disease progression or death, the assessment period was up to 36 months.
OS
Overall Survival
Measured: from the date of the first dose to the date of death for any reason, up to 3 years
iORR
Intracranial Objective Response Rate
Measured: From the first dose until the occurrence of intracranial progression or death (whichever occurs first), assessed up to 6 months.
iPFS
Intracranial Progression-Free Survival
Measured: From the date of the first dose to the date of the first documented intracranial progression, assessed for up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Solid TumorsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lixiaoling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lixiaoling, Beidahuang Industry Group General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387874
- Sponsor's protocol ID
- SHR-A1811-HLJ-002
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab Rezetecan Alone or in Combination for the Treatment of Patients With Recurrent or Metastatic Malignant Solid Tumors Expressing HER-2 Protein: A Single-Center, Real-World Study
- ClinicalTrials.gov ID
- NCT07387874
- Acronym / sponsor ID
- SHR-A1811-HLJ-002
- Conditions
- Recurrent or Metastatic Solid Tumors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LixiaolingUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 4 Feb 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.
To Observe and Evaluate the Safety Profile of Trastuzumab Rezetecan Alone or in Combination in Patients with HER-2 Protein-Expressing Recurrent or Metastatic Malignant Solid Tumors in a Real-World Setting.
Detailed description
Trastuzumab Rezetecan specifically binds to HER2 on the surface of tumor cells. The conjugate is subsequently internalized into the cells and transported to lysosomes, where the linker is cleaved by cathepsins to release the free toxin SHR169265. This payload inhibits the activity of DNA topoisomerase I, thereby inducing apoptosis in tumor cells. Owing to the high membrane permeability of SHR169265, a bystander killing effect is also observed: after being released inside tumor cells, it can diffuse into neighboring cells, exerting cytotoxic effects even on HER2-negative cells. This study aims to evaluate the efficacy and safety of Trastuzumab Rezetecan, either as monotherapy or in combination regimens, in patients with HER2-expressing recurrent or metastatic malignant solid tumors.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | – | Drug: Trastuzumab Rezetecan, Drug: Other DrugsTrastuzumab Rezetecan: ± Other Drugs |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Based on investigator assessment, patients with HER-2 protein-expressing recurrent or metastatic malignant solid tumors are eligible to receive trastuzumab, either as monotherapy or in combination therapy.
Key inclusion criteria (5 listed)
- Sign the informed consent form voluntarily and agree to participate in this study.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Age ≥ 18 years.
- HER2 protein expression (including IHC 1+, IHC 2+, IHC 3+, or IHC 0 with ≤10% of invasive tumor cells showing incomplete/weak membrane staining). HER2 protein expression test results must be within 2 years.
- Patients with advanced solid tumors who have failed, are intolerant to, or refuse standard therapy, and are deemed by the investigator as suitable to receive Trastuzumab Rezetecan monotherapy or combination therapy.
Key exclusion criteria (4 listed)
- Patients who are concurrently receiving other therapies of the same class.
- Patients currently enrolled in another interventional clinical study.
- Females with confirmed pregnancy or during lactation.
- Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this study.
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 |
|---|---|---|
| Trastuzumab RezetecanTrastuzumab Rezetecan: 4.8 mg/kg, administered every 21 days as one treatment cycle. Patients will receive treatment according to the investigator-defined regimen containing Trastuzumab Rezetecan until disease progression (PD), intolerable toxicity, patient-initiated withdrawal, or the occurrence of other medical events determined by the physician that make the combination therapy unsuitable for continuation. | Drug | Treatment arm |
| Other DrugsThe administration regimens for Trastuzumab Rezetecan include, but are not limited to: Combination with immune checkpoint inhibitors ± other agents Combination with targeted agents ± other agents Combination with radiotherapy ± other agents | Drug | Treatment arm |
Primary outcome
Safety （Incidence of Grade ≥3 AEs）
Time frame: From the first dose on Day 1 through the last dose, for up to 3 years
Safety （Incidence of Grade ≥3 AEs）
5 secondary outcomes
ORR
Time frame: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months
PFS
Time frame: From the first vaccination to the first recorded disease progression or death, the assessment period was up to 36 months.
OS
Time frame: from the date of the first dose to the date of death for any reason, up to 3 years
iORR
Time frame: From the first dose until the occurrence of intracranial progression or death (whichever occurs first), assessed up to 6 months.
iPFS
Time frame: From the date of the first dose to the date of the first documented intracranial progression, assessed for up to 3 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 4 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent or Metastatic Solid Tumors, run by Lixiaoling 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 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.
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?
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?
Safety （Incidence of Grade ≥3 AEs） (time frame: From the first dose on Day 1 through the last dose, for up to 3 years). 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 Feb 2026.