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SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors

RECRUITINGPhase 2Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.
Actively Recruiting
PhasePhase 2
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
Started2025-07-30
Est. completion2026-12-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07022002

Summary

This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Monotherapy and Combination Therapy in patients with advanced HER2-Expressing Solid Tumors.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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 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） v5. 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.

Conditions2

CancerLocally Advanced, Recurrent or Metastatic Malignancies

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