Evaluating SSGJ-705 for advanced malignant tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
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 |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06390774 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with documented advanced or recurrent metastatic malignancies and an ECOG performance status of 0-1.
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.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignancies.
How similar studies have performed: While this approach is novel, similar studies evaluating monotherapies for advanced malignancies have shown promising results.
Eligibility criteria
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 this trial is running
Jinan, Shandong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.