SSGJ-705: anti-PD-1 and anti-HER2 bispecifc antibody
SSGJ-612: anti-HER2 antibody
SSGJ-705 combined with chemotherapy: SSGJ-705 combined with chemotherapy
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Males and/or females over age 18
* Histologically and/or cytologically documented local advanced or metastatic Colorectal adenocarcinoma (CRC), Urothelial Cancer (UC), Breast Cancer (BC), Biliary Tract Carcinoma(BTC), Gastric/Gastroesophageal Junction Cancer （G/GEJC) , etc.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Expected survival \>3 months.
* Signed informed consent form.
Exclusion Criteria:
* Any remaining adverse events (AEs) \> grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（CTCAE） v6. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.
* Pregnant or nursing women or women/men who are ready to give birth
* symptomatic central nervous system metastasis.
* Allergy to other antibody drugs or any excipients in the study drugs.
* Inadequate organ or bone marrow function. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Primary outcome measure(s)
Objective response rate (ORR) — 12 months The primary efficacy end point
Incidence of Treatment-Emergent Adverse Events — 12 months The primary safety end point
Severity of Treatment-Emergent Adverse Events — 12 months The primary safety end point
Trial sites (1)
Facility
City
Region
Status
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
Recruiting
More Shenyang Sunshine Pharmaceutical Co., LTD. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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