Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SSGJ-705 · 3 trials · 2 indications
The primary efficacy end point
The primary safety end point
The primary safety end point
Dose limiting toxicity
Safety and tolerability assessed by incidence and severity of adverse events
maximum tolerated dose or the maximum administered dose if MTD is not reached
the recommended phase II dose
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | advanced gastric cancer and breast cancer that have failed standard treatment |
| Part 2 | EXPERIMENTAL | previously untreated advanced gastric cancer and lung cancer |
| Part 3 | EXPERIMENTAL | Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q3W IV. Dose extension will be carried out at the selected level. |
| Part 4 | EXPERIMENTAL | Indication extension will be carried out at the selected level，including 3 dosage levels. |
| Name | Type | Description |
|---|---|---|
| SSGJ-705 | DRUG | anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody |
| PD-1/L1 inhibitor combined with chemotherapy | DRUG | Immune checkpoint inhibitors |
| SSGJ-705 combined with chemotherapy | DRUG | anti-PD-1 and anti-HER2 bispecifc antibody |
| SSGJ-612 | DRUG | anti-HER2 antibody |
Inclusion Criteria: * Males and/or females over age 18. * Histologically and/or cytologically documented local advanced or metastatic non-Small Cell Lung Cancer（NSCLC），Breast Cancer（BC）or Gastric/Gastroesophageal Junction Cancer （G/GEJC). * Eastern Cooperative Oncology Group (ECOG) performance stat...
SSGJ-705 is an investigational small molecule being developed for the treatment of locally advanced, recurrent or metastatic malignancies, and locally advanced (unresectable) or metastatic solid tumors. It is currently being studied in patients with advanced malignant tumors and HER2-expressing solid tumors.
SSGJ-705 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SBFM. The company is conducting clinical trials of SSGJ-705 in China.
SSGJ-705 is currently in Phase 2 clinical development. It is being evaluated in a Phase 2 study as monotherapy and in combination therapy for advanced HER2-expressing solid tumors, as well as in a Phase 2 study combining SSGJ-705 with SSGJ-612 and chemotherapy.
SSGJ-705 is being studied in three clinical trials. NCT06390774 is a Phase 1 trial of SSGJ-705 monotherapy in advanced malignant tumors. NCT07022002 is a Phase 2 trial of SSGJ-705 monotherapy and combination therapy in HER2-expressing solid tumors. NCT07646626 is a Phase 2 trial of SSGJ-705 plus SSGJ-612 with or without chemotherapy.
SSGJ-705 is not FDA approved. It is an investigational drug currently in clinical development, with active Phase 1 and Phase 2 trials recruiting patients in China. Its safety and efficacy have not been established, and it has not been approved for any use.