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Also known as SSGJ-612 (HER2-targeted antibody)
SSGJ-612 · 2 trials · 2 indications
The primary efficacy end point
Adverse Events (AEs) refers to all adverse medical events that occur in patients after they receive the investigational drug and do not necessarily have a causal relationship with the investigational drug. AEs were evaluated according to CTCAE V5.0.
Dose-Limiting Toxicity
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | Breast cancer patients who have received at least one line of chemotherapy for metastatic disease |
| Part 2 | EXPERIMENTAL | Breast cancer patients who have not received any chemotherapy for metastatic disease |
| SSGJ-612 | EXPERIMENTAL | In dose escalation phase, participants will receive one of the five increasing dose levels of SSGJ-612 respectively, intravenously (IV). During or after dose escalation, any dose levels that does not exceed the MTD can be expanded. |
| Name | Type | Description |
|---|---|---|
| SSGJ-612 (HER2-targeted antibody) | DRUG | Intravenous injection |
| HER2-targeted ADC | DRUG | Intravenous injection |
| SSGJ-612 | DRUG | Intravenous injection |
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 cr...
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SSGJ-612 is an investigational small molecule being developed for metastatic breast cancer and advanced malignant tumors. It is currently in Phase 1 clinical development for advanced solid tumors and is also being studied in a Phase 2 trial for HR-positive, HER2-low or HER2-ultralow expression metastatic breast cancer.
SSGJ-612 targets HER2, as indicated by its classification as a HER2-targeted antibody. It is being studied in combination with a HER2-targeted antibody-drug conjugate for the treatment of HR-positive, HER2-low or HER2-ultralow expression metastatic breast cancer.
SSGJ-612 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials for this investigational drug in China.
SSGJ-612 is in Phase 1 clinical development, with an ongoing Phase 1 study in patients with advanced malignant tumors. Additionally, a Phase 2 study has been planned but has not yet started recruiting participants for metastatic breast cancer.
SSGJ-612 is being evaluated in two clinical trials. The first is NCT07032298, a Phase 1 study in patients with advanced solid tumors, currently recruiting in China. The second is NCT07757230, a Phase 2 study of SSGJ-612 plus a HER2-targeted ADC in HR-positive, HER2-low or HER2-ultralow expression metastatic breast cancer, which has not yet started recruiting.
Yes, SSGJ-612 is also known as a HER2-targeted antibody. It is being studied in combination with a HER2-targeted antibody-drug conjugate for the treatment of certain types of metastatic breast cancer.