Testing ZGGS18 in patients with advanced solid tumors
A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors
This study is testing a new drug called ZGGS18 in people with advanced solid tumors to see if it's safe and how well it works when other treatments haven't helped.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05584800 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety, tolerance, and pharmacokinetics of ZGGS18 in patients diagnosed with advanced solid tumors. It involves a dose escalation approach to determine the optimal dosage and includes multiple cohorts for expansion. Participants must have tumors that have not responded to standard treatments or for which no standard treatment is available. The study aims to gather data on the drug's effectiveness and safety profile in this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced solid tumors who have failed standard treatments or have no available options.
Not a fit: Patients with early-stage tumors or those who are not suitable for the trial as determined by the investigator may not benefit.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted other treatment avenues.
How similar studies have performed: While this approach is not widely tested, similar studies targeting advanced solid tumors have shown promise in developing new treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Life expectancy ≥ 3 months; * Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions. Exclusion Criteria: * The investigator considers that any subjects are not suitable to participate in the trial.
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shangdi Ning
- Email: ningsd@zelgen.com
- Phone: +86-0512-57018308
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.