NCT07646626 SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors
| NCT ID | NCT07646626 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. |
| Condition | Locally Advanced (Unresectable) or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-07-31 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2026-07-31 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07646626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced (Unresectable) or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07646626 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07646626 currently recruiting?
Yes, NCT07646626 is actively recruiting participants. Contact the research team at hzyingjieer@163.com for enrollment information.
Where is the NCT07646626 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07646626 clinical trial?
NCT07646626 is sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. The trial plans to enroll 150 participants.