NCT07757230Not yet recruitingPhase 2
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
Shenyang Sunshine Pharmaceutical Co., LTD.1 site in 1 country87 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Part 1
Experimental
Breast cancer patients who have received at least one line of chemotherapy for metastatic disease
Intervention: SSGJ-612 (HER2-targeted antibody) (Drug)
Part 1
Experimental
Breast cancer patients who have received at least one line of chemotherapy for metastatic disease
Intervention: HER2-targeted ADC (Drug)
Part 2
Experimental
Breast cancer patients who have not received any chemotherapy for metastatic disease
Intervention: SSGJ-612 (HER2-targeted antibody) (Drug)
Part 2
Experimental
Breast cancer patients who have not received any chemotherapy for metastatic disease
Intervention: HER2-targeted ADC (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: 2 years
The primary efficacy end point
Secondary Outcomes
- Incidence and Severity of Adverse Events (AEs)(2 years)
- Progression-Free-Survival (PFS)(2 years)
Investigators
Study Sites (1)
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