A Phase 2 interventional study of SSGJ-705 and SSGJ-612 in Locally Advanced (Unresectable) or Metastatic Solid Tumors, sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD. (part of 3SBio Inc.) · Phase 2, Interventional, and Treatment
This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in patients with advanced HER2-Expressing Solid Tumors.
This study includes 2 Parts: Part 1 (SSGJ-705 Plus SSGJ-612 for advanced cancer that have failed standard treatment), and Part 2 (SSGJ-705 or SSGJ-705 Plus SSGJ-612 in combination with chemotherapy for previously untreated advanced gastric cancer).
Shenyang Sunshine Pharmaceutical Co., LTD. is the lead sponsor of 40 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
advanced cancer that have failed standard treatment
Drug: SSGJ-705 · Drug: SSGJ-612
previously untreated advanced gastric cancer
Drug: SSGJ-612 · Drug: SSGJ-705 combined with chemotherapy
anti-PD-1 and anti-HER2 bispecifc antibody
anti-HER2 antibody
Drug page: Anti-HER2/Anti-PD-1 Bispecific Antibody SSGJ-705
SSGJ-705 combined with chemotherapy
Objective response rate (ORR)
The primary efficacy end point
Time frame: 12 months
Incidence of Treatment-Emergent Adverse Events
The primary safety end point
Time frame: 12 months
Severity of Treatment-Emergent Adverse Events
The primary safety end point
Time frame: 12 months
Progression-Free-Survival (PFS)
The secondary efficacy end point
Time frame: 24 months
Plan to share: No
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Studies of the drug tested here: Anti-HER2/Anti-PD-1 Bispecific Antibody SSGJ-705
Shenyang Sunshine Pharmaceutical Co., LTD. →