Advanced Metastatic Triple-negative Breast Cancer (mTNBC)Early Phase 1NCT07340424
A Prospective, Open-label, Single-arm, Exploratory Clinical Trial to Evaluate the Safety and Tolerability of 225Ac-TR2205 Injection in Patients With Triple-negative Breast Cancer.
A Early Phase 1 study testing 225Ac-TR2205 Injection in people with Advanced Metastatic Triple-negative Breast Cancer (mTNBC), run by Xiaorong Sun at 1 site in China.
Trial summary
This study is a prospective, single-center, single-arm, open-label research. It evaluates the safety and tolerability of 225Ac-TR2205 in patients with triple-negative breast cancer (TNBC), and assesses its radiation dosimetry and initial efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Metastatic Triple-negative Breast Cancer (mTNBC)
- What is being tested?
- 225Ac-TR2205 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2025to May 2029
- Phase
- Early Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the study and signing of the informed consent form.
- Female patients aged 18 years and above.
- Patients with triple-negative breast cancer who have been diagnosed by histopathology [immune histochemistry estrogen receptor (ER) positive rate < 1% is defined as ER negative expression; progesterone receptor (PR) positive rate < 1% is defined as PR negative; human epidermal growth factor receptor 2 (HER2) expression 0-1+ or HER2 ++ but fluorescence in situ hybridization/colorimetric in situ hybridization (FISH/CISH) negative is defined as HER2 negative expression].
- Patients with metastatic triple-negative breast cancer who have received at least 2 systemic treatments (at least 1 of which is for metastatic disease).
- Patients with at least 1 measurable lesion (tumor evaluation according to RECIST 1.1).
- ECOG performance status assessment of 0-1.
- Clinical significance of hematological toxicity related to previous treatment must recover to ≤ 2 grade, and non-hematological toxicity ≤ 1 grade (except for hair loss).
- For patients with reproductive potential: 7 days before the first administration, fertile women must confirm that the urine pregnancy test is negative and agree to use effective contraceptive measures during the use of the study drug and within 6 months after the last administration (such as oral contraceptives, intrauterine devices, restraint of sexual desire or barrier contraception combined with spermicides, etc.).
Who cannot join
- Patients who received radiotherapy (except palliative radiotherapy) or chemotherapy, immunotherapy within 3 weeks before treatment, except for bisphosphonates (which can be used for bone metastasis), are excluded.
- Patients who received radionuclide therapy within 6 months before enrollment, such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, lutetium-177, actinium-225, or whole-body radiotherapy.
- Patients who are undergoing chemotherapy, immunotherapy, biological therapy, off-label radionuclide therapy, or other investigational treatments.
- Patients who have undergone major surgery within 28 days before enrollment.
- Patients evaluated by the investigator are expected to have a life expectancy of less than 3 months.
- Bone scans show super bone imaging, defined as uniform and significant concentration of radioactive isotopes in the entire skeleton relative to soft tissue, while the urinary system is not visible or shows mild visibility.
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- Symptomatic spinal cord compression, or clinical or imaging evidence suggesting impending spinal cord compression.
- Patients with uncontrollable central nervous system (CNS) metastases, who need symptomatic treatment with glucocorticoids or mannitol, and if necessary, enhanced CT or MRI to clarify the status of brain metastases.
- Patients with a history of other malignant tumors, except for those with fully treated malignant tumors that have survived without treatment for more than 3 years without recurrence or progression, or patients with fully treated non-melanoma skin cancer and superficial bladder cancer.
- Patients with a history that may interfere with the purpose of the study and assessment, or the investigator determines that the patient has any condition that cannot cooperate with imaging examinations, treatment, and procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong
About this study
This study is a prospective, single-center, single-arm, open-label research. It evaluates the safety and tolerability of 225Ac-TR2205 in patients with triple-negative breast cancer (TNBC), and assesses its radiation dosimetry and initial efficacy.
- Being tested
- 225Ac-TR2205 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
225Ac-TR2205 InjectionDrug
Patients will receive 225Ac-TR2205 injection administration at an interval of 8 weeks between each dose.
| Study group | Role | What they receive |
|---|---|---|
| 225Ac-TR2205 Injection | Experimental | Not described Receives: Drug: 225Ac-TR2205 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity grades of adverse events (AE), serious adverse events (SAE), and unexpected serious adverse reactions (SUSAR) were evaluated according to the CTCAE 5.0 standard.
Measured: 8 weeks 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 posted14 Jan 2026
- Study start22 May 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Metastatic Triple-negative Breast Cancer (mTNBC)Studies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaorong Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaorong Sun, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340424
- Sponsor's protocol ID
- TR2205-305
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-arm, Exploratory Clinical Trial to Evaluate the Safety and Tolerability of 225Ac-TR2205 Injection in Patients With Triple-negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT07340424
- Acronym / sponsor ID
- TR2205-305
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Xiaorong SunUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 14 Jan 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 study is a prospective, single-center, single-arm, open-label research. It evaluates the safety and tolerability of 225Ac-TR2205 in patients with triple-negative breast cancer (TNBC), and assesses its radiation dosimetry and initial efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 225Ac-TR2205 Injection | Experimental | Drug: 225Ac-TR2205 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary participation in the study and signing of the informed consent form.
- Female patients aged 18 years and above.
- Patients with triple-negative breast cancer who have been diagnosed by histopathology [immune histochemistry estrogen receptor (ER) positive rate < 1% is defined as ER negative expression; progesterone receptor (PR) positive rate < 1% is defined as PR negative; human epidermal growth factor receptor 2 (HER2) expression 0-1+ or HER2 ++ but fluorescence in situ hybridization/colorimetric in situ hybridization (FISH/CISH) negative is defined as HER2 negative expression].
- Patients with metastatic triple-negative breast cancer who have received at least 2 systemic treatments (at least 1 of which is for metastatic disease).
- Patients with at least 1 measurable lesion (tumor evaluation according to RECIST 1.1).
Key exclusion criteria (10 listed)
- Patients who received radiotherapy (except palliative radiotherapy) or chemotherapy, immunotherapy within 3 weeks before treatment, except for bisphosphonates (which can be used for bone metastasis), are excluded.
- Patients who received radionuclide therapy within 6 months before enrollment, such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, lutetium-177, actinium-225, or whole-body radiotherapy.
- Patients who are undergoing chemotherapy, immunotherapy, biological therapy, off-label radionuclide therapy, or other investigational treatments.
- Patients who have undergone major surgery within 28 days before enrollment.
- Patients evaluated by the investigator are expected to have a life expectancy of less than 3 months.
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 |
|---|---|---|
| 225Ac-TR2205 InjectionPatients will receive 225Ac-TR2205 injection administration at an interval of 8 weeks between each dose. | Drug | 225Ac-TR2205 Injection |
Primary outcome
The incidence and severity grades of adverse events (AE), serious adverse events (SAE), and unexpected serious adverse reactions (SUSAR) were evaluated according to the CTCAE 5.0 standard.
Time frame: 8 weeks after the last dose
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 14 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 225Ac-TR2205 Injection in people with Advanced Metastatic Triple-negative Breast Cancer (mTNBC), run by Xiaorong Sun 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 8 inclusion and 10 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 14 Jan 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xiaorong Sun (0531-67626287, xrsun@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity grades of adverse events (AE), serious adverse events (SAE), and unexpected serious adverse reactions (SUSAR) were evaluated according to the CTCAE 5.0 standard. (time frame: 8 weeks after the last dose). 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 14 Jan 2026.