Evaluating JS207 for patients with advanced malignant tumors
A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
This study is testing a new treatment called JS207 to see if it is safe and effective for people with advanced malignant tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06022250 on ClinicalTrials.gov |
What this trial studies
This Phase I open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of JS207 in patients with advanced malignant tumors. The study will determine the recommended dose for future trials based on these evaluations. Participants will receive JS207 and be monitored for various outcomes related to their condition and treatment response.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced malignant tumors confirmed by histology or pathology who have failed standard treatments and have a life expectancy of at least 12 weeks.
Not a fit: Patients with central nervous system metastasis or those with symptomatic effusions requiring management 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 malignant tumors who have exhausted standard treatment options.
How similar studies have performed: While this approach is being explored in this specific context, similar studies evaluating novel treatments for advanced tumors have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable; 2. Eastern Cooperative Oncology Group (ECOG) 0 or 1; 3. Life expectancy ≥ 12 weeks; 4. At least one measurable lesion according to RECIST 1.1; 5. Adequate organ function; Exclusion Criteria: 1. central nervous system metastasis； 2. There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)； 3. Images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk； 4. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures； 5. A history of significant bleeding tendency or severe coagulopathy； 6. The presence of poorly controlled hypertension；
Where this trial is running
Jinan, Shandong
- Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Chaoqiang Yang, Master
- Email: chaoqiang_yang@junshipharma.com
- Phone: +86 18252095266
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.