Advanced Solid TumorPhase 1/2NCT05584800
Study of ZGGS18 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing ZGGS18 for Injection in people with Advanced Solid Tumor, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2022to 1 Nov 2026
- 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
- Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 3 months;
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.
Who cannot join
- The investigator considers that any subjects are not suitable to participate in the trial.
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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jianming Xu, Jianmingxu2014@163.com
About this study
Official title: A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
- Conditions
- Advanced Solid Tumor
- Being tested
- ZGGS18 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZGGS18 for InjectionBiological
0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kgof ZGGS18，intravenous infusion, once every 2 weeks.
ZGGS18 for InjectionBiological
Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Not described Receives: Biological: ZGGS18 for Injection |
| Dose Expansion | Experimental | Tumor type: colorectal cancer，pancreatic cancer Receives: Biological: ZGGS18 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of ZGGS18
Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Measured: 28 days
Safety of ZGGS18
Number of participants with adverse events/abnormal laboratory values that are related to treatment
Measured: Through study completion, an expected average of 3 years
Secondary outcomes (13)
Pharmacokinetic characteristics of ZGGS18
Peak Plasma Concentration (Cmax)
Measured: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Time to maximum concentration (Tmax)
Measured: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Clearance (CL/F)
Measured: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Area under drug concentration-time curve
Measured: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Elimination rate constant (Ke)
Measured: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Elimination half-life (t1/2)
Measured: Through Phase I study completion, an expected average of 1 year
Immunogenicity of ZGGS18
Detection of anti-drug antibodies, if positive, further detection of neutralizing antibodies. Counting the number of patients and incidence of anti-drug antibodies and neutralizing antibodies
Measured: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Objective response rate
Measured: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Progression-free survival
Measured: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Disease control rate
Measured: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Duration of response
Measured: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Time to response
Measured: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Time to progression
Measured: Through study completion, an expected average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start15 Nov 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (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
- 222 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 director, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584800
- Sponsor's protocol ID
- ZGGS18-001
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2022
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05584800
- Acronym / sponsor ID
- ZGGS18-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 18 Oct 2022 (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.
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: ZGGS18 for Injection |
| Dose Expansion | Experimental | Biological: ZGGS18 for InjectionTumor type: colorectal cancer，pancreatic cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 3 months;
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.
Key exclusion criteria (1 listed)
- The investigator considers that any subjects are not suitable to participate in the trial.
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 Injection0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kgof ZGGS18，intravenous infusion, once every 2 weeks. | Biological | Dose Escalation |
| ZGGS18 for InjectionRecommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks. | Biological | Dose Expansion |
Primary outcome
Tolerability of ZGGS18
Time frame: 28 days
Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Safety of ZGGS18
Time frame: Through study completion, an expected average of 3 years
Number of participants with adverse events/abnormal laboratory values that are related to treatment
13 secondary outcomes
Pharmacokinetic characteristics of ZGGS18
Time frame: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Time frame: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Time frame: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Time frame: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Time frame: Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18
Time frame: Through Phase I study completion, an expected average of 1 year
Immunogenicity of ZGGS18
Time frame: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Time frame: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Time frame: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Time frame: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Time frame: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Time frame: Through study completion, an expected average of 3 years
Efficacy of ZGGS18
Time frame: Through study completion, an expected average of 3 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.
- Individual participant dataSharing planned: No
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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 director
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 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 4 inclusion and 1 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 Shangdi Ning (+86-0512-57018308, ningsd@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of ZGGS18 (time frame: 28 days). The study lists 2 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.