Advanced Solid TumorPhase 1/2NCT06938880
Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing ZGGS18 for Injection and ZG005 for Injection in people with Advanced Solid Tumor, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ZGGS18 for Injection and ZG005 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Li Zhang
About this study
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
This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.
- Conditions
- Advanced Solid Tumor
- Being tested
- ZGGS18 for Injection, ZG005 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZGGS18 for InjectionBiological
Also called ZGGS18
Intravenous infusion
ZG005 for InjectionBiological
Also called ZG005
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | ZG005 will be given 10mg/kg or 20mg/kg or other dose every three weeks and ZGGS18 will be given 10 mg/kg every three weeks Receives: Biological: ZGGS18 for Injection; Biological: ZG005 for Injection |
| Phase 2 Dose Expansion | Experimental | ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks Receives: Biological: ZGGS18 for Injection; Biological: ZG005 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity(DLT)
Incidence and severity of DLT events
Measured: up to 21 days
Adverse Event (AE)
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Measured: Up to 2 years
Maximum tolerated dose(MTD)
Measured: Up to 1 years
Recommended phase II dose(RP2D)
Measured: Up to 1 years
Secondary outcomes (2)
Objective response rate (ORR)
Objective Response Rate as Assessed by Investigator according to RECIST v1.1
Measured: Up to 2 years
Immunogenicity
Incidence of antidrug antibodies (ADA)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start20 May 2025
- Primary completionMay 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938880
- Sponsor's protocol ID
- ZGGS18-ZG005-001
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06938880
- Acronym / sponsor ID
- ZGGS18-ZG005-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Biological: ZGGS18 for Injection, Biological: ZG005 for InjectionZG005 will be given 10mg/kg or 20mg/kg or other dose every three weeks and ZGGS18 will be given 10 mg/kg every three weeks |
| Phase 2 Dose Expansion | Experimental | Biological: ZGGS18 for Injection, Biological: ZG005 for InjectionZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZGGS18 for InjectionAlso: ZGGS18Intravenous infusion | Biological | Phase 1 Dose Escalation, Phase 2 Dose Expansion |
| ZG005 for InjectionAlso: ZG005Intravenous infusion | Biological | Phase 1 Dose Escalation, Phase 2 Dose Expansion |
Primary outcome
Dose limited toxicity(DLT)
Time frame: up to 21 days
Incidence and severity of DLT events
Adverse Event (AE)
Time frame: Up to 2 years
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Maximum tolerated dose(MTD)
Time frame: Up to 1 years
Recommended phase II dose(RP2D)
Time frame: Up to 1 years
2 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 2 years
Immunogenicity
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZGGS18 for Injection and ZG005 for Injection in people with Advanced Solid Tumor, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siqi Jia (+86-0512-57018310, jiasy@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity(DLT) (time frame: up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.