Test a combination of SSGJ-705 and SSGJ-612 (with or without chemotherapy) in advanced HER2-expressing solid cancers
Official title: A Phase II Study of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors
Run by Shenyang Sunshine Pharmaceutical Co., LTD. · NCT07646626 · Data updated 2026-11-12
This phase 2 study tests whether SSGJ-705 plus SSGJ-612, with or without chemotherapy, can help adults with advanced HER2-expressing solid tumors like colorectal, urothelial, breast, gastric, or biliary cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | July 17, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | October 31, 2028 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07646626 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with locally advanced or metastatic HER2-expressing solid tumors such as CRC, UC, BC, BTC, or G/GEJC, who have adequate organ function and ECOG 0-1.
✕Probably not a fit
Patients with tumors that do not respond to HER2-targeted regimens or who discontinue due to toxicity may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label phase 2 trial has two parts: Part 1 evaluates SSGJ-705 plus SSGJ-612 in patients whose cancers have progressed after standard treatments, and Part 2 examines SSGJ-705 alone or with SSGJ-612 plus chemotherapy in previously untreated advanced gastric cancer. Participants are adults with locally advanced or metastatic solid tumors that express HER2, and they must have good performance status and organ function. The study aims to assess safety and efficacy of the regimens, with ongoing monitoring for adverse events and tumor response. Primary endpoints typically include safety tolerability and objective response, with exploratory assessments of progression-free survival and biomarker data.
Why it matters
Potential benefit: If successful, participants may experience tumor control or slowed disease progression and potential improvements in symptoms or survival.
How similar studies have gone: Early-phase studies in HER2-expressing cancers have shown signals of activity with multi-agent regimens, though this exact combination is being evaluated prospectively here.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Jieer Ying, M.D.
- Email: hzyingjieer@163.com
- Phone: +86-13858195803
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.