Evaluating SSGJ-705 for advanced malignant tumors
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
Run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · NCT06390774 · Data updated 2026-11-12
This study is testing a new treatment called SSGJ-705 to see if it is safe and effective for people with advanced cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | May 30, 2024 |
| Main results expected | December 2026 |
| Study ends | February 2027 |
| Registry record updated | October 18, 2024 |
| Trial ID | NCT06390774 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with documented advanced or recurrent metastatic malignancies and an ECOG performance status of 0-1.
✕Probably not a fit
Patients with symptomatic central nervous system metastasis or severe dyspnea due to complications of advanced tumors may not benefit from this study.
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 I study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of SSGJ-705 as a monotherapy in patients with advanced malignancies. The study is divided into four parts, focusing on different dosing schedules and specific tumor characteristics, including HER2 expression and PD-L1 levels. Participants will receive SSGJ-705 in escalating doses to determine the optimal administration frequency and evaluate its effects on various types of advanced tumors.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignancies.
How similar studies have gone: While this approach is novel, similar studies evaluating monotherapies for advanced malignancies have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and/or females over age 18 2. Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>3 months. 5. Signed informed consent form. 6. Must have adequate organ function. Exclusion Criteria: 1. Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity. 2. Pregnant or nursing women or women/men who are ready to give birth 3. Symptomatic central nervous system metastasis. 4. Allergy to other antibody drugs or any excipients in the study drugs. 5. Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy. 6. Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) . 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
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Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Jinming Yu, MD,Ph.D
- Email: sdyujinming@126.com
- Phone: +86-13806406293
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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.