RecruitingPhase 2NCT07646626

SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors

A Phase II Study of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Enrollment

150 participants

Start Date

Jul 31, 2026

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria5

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.

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