Testing ZGGS18 in patients with advanced solid tumors
Official title: A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors
Run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT05584800 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 222 (estimated) |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | November 15, 2022 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT05584800 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with advanced solid tumors who have failed standard treatments or have no available options.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is not widely tested, similar studies targeting advanced solid tumors have shown promise in developing new treatments.
Who can join: the full rules
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 it's running
-
Chinese PLA General Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Shangdi Ning
- Email: ningsd@zelgen.com
- Phone: +86-0512-57018308
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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-
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This study tests ARV-6723, by itself or with pembrolizumab, to see if it is safe and could help the immune system fight advanced solid tumors in adults.
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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.