SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSGJ-705, SSGJ-612, SSGJ-705 combined with chemotherapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced (Unresectable) or Metastatic Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Study of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors
Overview
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.
Detailed description
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).
Interventions
- Drug SSGJ-705
anti-PD-1 and anti-HER2 bispecifc antibody - Drug SSGJ-612
anti-HER2 antibody - Drug SSGJ-705 combined with chemotherapy
SSGJ-705 combined with chemotherapy
Primary outcome measures
- Objective response rate (ORR) [Time frame: 12 months]
- Incidence of Treatment-Emergent Adverse Events [Time frame: 12 months]
- Severity of Treatment-Emergent Adverse Events [Time frame: 12 months]
Secondary outcome measures (1)
- Progression-Free-Survival (PFS) [Time frame: 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07646626 · SSGJ-705-202