ZGGS18 and ZG005 combination for advanced solid tumors
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors, Including Cervical Cancer, Hepatocellular Carcinoma, Neuroendocrine Tumors, and Lung Cancer
This tests whether giving ZGGS18 together with ZG005 is safe and might help adults (18–75) with advanced solid tumors who have not responded to standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06938880 on ClinicalTrials.gov |
What this trial studies
This interventional Phase 1/2 protocol gives ZGGS18 and ZG005 by injection to adults with advanced solid tumors, including cervical, hepatocellular, neuroendocrine, and lung cancers. The study monitors tolerability, safety, blood drug levels (pharmacokinetics), and preliminary signs of anti-tumor activity. Adults who have failed or are intolerant of standard therapies and meet imaging and pathology criteria may enroll, while patients with CNS metastases or recent other cancers are excluded. All visits and dosing occur at the study site in Guangzhou with scheduled safety and response assessments.
Who should consider this trial
Good fit: Adults aged 18–75 with histologically or cytologically confirmed advanced solid tumors who have exhausted or cannot tolerate standard treatments and meet other eligibility criteria are ideal candidates.
Not a fit: Patients with central nervous system metastases, a second malignancy within five years, or other conditions judged unsuitable by the investigator are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combination could provide a new treatment option that controls tumor growth with acceptable side effects for some patients with advanced solid tumors.
How similar studies have performed: While combination therapies have shown benefit in some advanced solid tumors, the ZGGS18 plus ZG005 pairing appears novel and has limited published clinical data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fully understand this study and voluntarily sign the ICF. * Age 18-75 years, no gender restriction. * Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology. Exclusion Criteria: * Medical history, CT scan, or MRI indicates the presence of CNS metastases. * Other malignancies within 5 years. * Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Siqi Jia
- Email: jiasy@zelgen.com
- Phone: +86-0512-57018310
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.