ZGGS18 and ZG005 combination for advanced solid tumors
Official title: 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
Run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT06938880 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | May 2027 |
| Study ends | April 2028 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT06938880 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Siqi Jia
- Email: jiasy@zelgen.com
- Phone: +86-0512-57018310
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SGT003 in people with advanced solid tumors
This early-phase study tests SGT003 in adults with advanced solid tumors to see if it is safe and tolerable and to get a first look at how it behaves in the body and any early signs of benefit.
-
YSCH-01 Nebulized Therapy for Lung Metastases in NSCLC and Advanced Solid Tumors
A first-in-human, early-phase study tests a nebulized therapy called YSCH-01 to see if it is safe and shows any signs of benefit for adults with NSCLC or other cancers that have spread to the lungs.
-
Personalized neoantigen-pulsed dendritic cell injections for malignant solid tumors
This study tests personalized dendritic cell injections, with or without immune checkpoint inhibitors, to see if they are safe and can help patients with advanced solid tumors.
-
STX-003 in advanced solid tumors given by IV, alone or with pembrolizumab
This study tests STX-003, given by IV, to see if it is safe and potentially effective for patients with advanced solid tumors, either alone or with pembrolizumab.
-
ARV-6723 alone or with pembrolizumab in adults with advanced solid tumors
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.
-
BG-85738 alone or with other anticancer drugs in RAS-mutant advanced or metastatic solid tumors
This study tests BG-85738, alone or with other cancer drugs, in adults whose solid tumors have RAS mutations and have progressed.
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.