> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/ssgj-705-monotherapy-and-combination-therapy-in-advanced-7ee12643-02b6-4bd1-912e-6c7455450297 > Record changed: 2026-10-29 # SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors NCT07022002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) Participants 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) Lead sponsor Shenyang Sunshine Pharmaceutical Co., LTD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) Start date 2025-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Short title** SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Official title** A Phase II Study to Evaluate the Safety and Efficacy of SSGJ-705 Monotherapy and Combination Therapy in Patients With Advanced HER2-Expressing Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Dates **Completion date** 2027-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **First posted** 2025-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Registry last updated** 2025-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Primary completion date** 2026-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Start date** 2025-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Size and sites **Participants** 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Planned participants** 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Lead sponsor** Shenyang Sunshine Pharmaceutical Co., LTD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Identifiers **Registry ID** NCT07022002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **ClinicalTrials.gov ID** NCT07022002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Outcomes ### Primary outcomes 1. Objective response rate (ORR) Timeframe: 12 months The primary efficacy end point 2. Incidence of Treatment-Emergent Adverse Events Timeframe: 12 months The primary safety end point 3. Severity of Treatment-Emergent Adverse Events Timeframe: 12 months The primary safety end point ### Secondary outcomes 1. Progression-Free-Survival (PFS) Timeframe: 24 months The secondary efficacy end point Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Sites - Zhejiang Cancer HospitalHangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07022002) ## Related records ### Drugs (1) - [Gilvetmab](https://trialight.com/data/asset/gilvetmab-4079fd36-a0c4-44f0-96bd-7888b5841291.md) ### Lead sponsors (1) - [Shenyang Sunshine Pharmaceutical Co., LTD.](https://trialight.com/data/company/shenyang-sunshine-pharmaceutical-co-ltd-361b04b2-f75d-4515-9b21-94300e45d618.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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