Combining ZG005 with Donafenib for advanced solid tumors
A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor
This study is testing whether combining two treatments, ZG005 and Donafenib, can help people with advanced solid tumors feel better and manage their condition.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06239298 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of ZG005 when combined with Donafenib in patients suffering from advanced solid tumors. It is a multi-center, open-label study that includes both Phase I and Phase II assessments. The trial aims to determine how well these treatments work together and their potential side effects in a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with advanced solid tumors and an ECOG performance status of 0.
Not a fit: Patients who are not suitable for participation as determined by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with advanced solid tumors.
How similar studies have performed: While there may be other studies exploring similar combinations, the specific approach of ZG005 with Donafenib is novel and has not been extensively tested.
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 or * Life expectancy ≥ 3 months. Exclusion Criteria: * Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Where this trial is running
Chongqing, Chongqing Municipality
- The Second Affiliated Hospital of Army Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Cheng Wei
- Email: weic@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.