Metastatic Breast CancerPhase 2NCT07757230
A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
A Phase 2 study testing SSGJ-612 (HER2-targeted antibody) and HER2-targeted ADC in people with Metastatic Breast Cancer, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- SSGJ-612 (HER2-targeted antibody) and HER2-targeted ADC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2026to Jul 2029
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in this study, signed informed consent form, good treatment compliance, and willingness to cooperate to complete all trial procedures.
- Expected survival duration ≥ 3 months.
- Histopathologically confirmed breast cancer meeting all of the following criteria simultaneously:
- Metastatic tumor;
- Tumor samples tested by central laboratory confirmed as HER2-low or HER2 ultra-low expression;
- No prior test results reporting HER2 positivity;
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- Tumor sample testing confirms hormone receptor-positive (HR+) status.
- Patients must satisfy either of the following conditions:
- Disease progression within 6 months after initiation of first-line endocrine therapy combined with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors for metastatic disease;
- Received at least 2 lines of prior endocrine therapy for metastatic disease, with disease progression post-treatment.
- Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease.
- At least one repeatedly and accurately measurable tumor lesion as target lesion assessed per RECIST v1.1 criteria.
Who cannot join
- Uncontrolled or severe cardiovascular disease.
- History of interstitial lung disease (ILD)/pneumonia requiring corticosteroid therapy (non-infectious), or current ILD/pneumonia, or suspected ILD/pneumonia not excluded by screening imaging.
- Presence of pulmonary-specific, clinically significant comorbid conditions.
- Presence of spinal cord compression, or clinically active central nervous system metastases.
- Female patients who are pregnant, breastfeeding, or planning pregnancy.
- Patients who received investigational drug therapy in another clinical trial within 30 days prior to first study drug administration, or who are concurrently enrolled in another clinical trial. Note: Exclusions include participation in observational (non-interventional) clinical trials, or being in the follow-up phase of an interventional clinical trial.
- Presence of drug abuse, or other diseases (e.g., psychiatric disorders) that, in the investigator's judgment, may interfere with patient participation in the trial or affect the assessment of trial outcomes.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Shusen Wang M.D., +86 139 2616 8469, wangshus@susucc.org.cn
About this study
Official title: A Phase II Clinical Study of SSGJ-612 in Combination With a Human Epidermal Growth Factor Receptor 2 (HER2)-Targeted Antibody-Drug Conjugate (ADC) in Patients With Hormone Receptor (HR)-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow metastatic breast cancer.
Read the detailed description
The study is divided into two parts: Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease.
- Conditions
- Metastatic Breast Cancer
- Being tested
- SSGJ-612 (HER2-targeted antibody), HER2-targeted ADC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-612 (HER2-targeted antibody)Drug
Intravenous injection
HER2-targeted ADCDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Breast cancer patients who have received at least one line of chemotherapy for metastatic disease Receives: Drug: SSGJ-612 (HER2-targeted antibody); Drug: HER2-targeted ADC |
| Part 2 | Experimental | Breast cancer patients who have not received any chemotherapy for metastatic disease Receives: Drug: SSGJ-612 (HER2-targeted antibody); Drug: HER2-targeted ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The primary efficacy end point
Measured: 2 years
Secondary outcomes (2)
Incidence and Severity of Adverse Events (AEs)
The secondary safety end point
Measured: 2 years
Progression-Free-Survival (PFS)
The secondary efficacy end point
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start21 Sep 2026
- Primary completionFeb 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757230
- Sponsor's protocol ID
- SSGJ-612-201
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of SSGJ-612 in Combination With a Human Epidermal Growth Factor Receptor 2 (HER2)-Targeted Antibody-Drug Conjugate (ADC) in Patients With Hormone Receptor (HR)-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07757230
- Acronym / sponsor ID
- SSGJ-612-201
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 11 Aug 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 phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow metastatic breast cancer.
Detailed description
The study is divided into two parts: Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: SSGJ-612 (HER2-targeted antibody), Drug: HER2-targeted ADCBreast cancer patients who have received at least one line of chemotherapy for metastatic disease |
| Part 2 | Experimental | Drug: SSGJ-612 (HER2-targeted antibody), Drug: HER2-targeted ADCBreast cancer patients who have not received any chemotherapy for metastatic disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary participation in this study, signed informed consent form, good treatment compliance, and willingness to cooperate to complete all trial procedures.
- Expected survival duration ≥ 3 months.
- Histopathologically confirmed breast cancer meeting all of the following criteria simultaneously:
- Patients must satisfy either of the following conditions:
- Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease.
Key exclusion criteria (7 listed)
- Uncontrolled or severe cardiovascular disease.
- History of interstitial lung disease (ILD)/pneumonia requiring corticosteroid therapy (non-infectious), or current ILD/pneumonia, or suspected ILD/pneumonia not excluded by screening imaging.
- Presence of pulmonary-specific, clinically significant comorbid conditions.
- Presence of spinal cord compression, or clinically active central nervous system metastases.
- Female patients who are pregnant, breastfeeding, or planning pregnancy.
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 |
|---|---|---|
| SSGJ-612 (HER2-targeted antibody)Intravenous injection | Drug | Part 1, Part 2 |
| HER2-targeted ADCIntravenous injection | Drug | Part 1, Part 2 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
The primary efficacy end point
2 secondary outcomes
Incidence and Severity of Adverse Events (AEs)
Time frame: 2 years
Progression-Free-Survival (PFS)
Time frame: 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 14 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSGJ-612 (HER2-targeted antibody) and HER2-targeted ADC in people with Metastatic Breast Cancer, run by Shenyang Sunshine Pharmaceutical 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 12 inclusion and 7 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 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 phase mean?
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 Shusen Wang M.D. (+86 139 2616 8469, wangshus@susucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 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 14 Oct 2026.