Testing ZG005 for advanced solid tumors
A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors
PHASE1; PHASE2 · Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT06233292
This study is testing a new drug called ZG005 to see if it can safely help people with advanced solid tumors.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 484 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd (industry) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06233292 on ClinicalTrials.gov |
What this trial studies
This is a multi-center, open-label study evaluating the safety and efficacy of ZG005 in patients with advanced solid tumors. The study consists of three stages, including dose escalation and confirmation of the maximum tolerated dose (MTD) or recommended dose. Participants will receive ZG005 Powder for Injection as part of the treatment regimen. 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 adults aged 18-70 with a confirmed diagnosis of advanced solid tumors and an ECOG performance status of 0-2.
Not a fit: Patients with central nervous system metastases or those who have had another malignancy within the past 5 years 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 solid tumors.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating advanced solid tumors with novel agents.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Male or female 18-70 years of age; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2; * Life expectancy ≥ 3 months; * Histologically or cytologically confirmed diagnosis of advanced solid tumors. Exclusion Criteria: * Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases; * Any other malignancy within 5 years.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Yongsheng Chu
- Email: chuys@zelgen.com
- Phone: +86-0512-57309965
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.
Conditions: Solid Tumors