Advanced Solid TumorPhase 2NCT06927687
Study of ZG005 in Patients With Advanced Solid Tumors
A Phase 2 study testing ZG005 for Injection in people with Advanced Solid Tumor, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This is an open-label, multicenter, Phase II clinical trial, designed to evaluate the efficacy and safety of ZG005 in patients with advanced solid tumors who have previously failed or are intolerant to standard treatment. 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?
- ZG005 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2025to Jun 2027
- Phase
- Phase 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 the study and voluntarily sign the informed consent form.
- Male or female 18-75 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
- Life expectancy ≥ 12 weeks;
- Histologically or cytologically confirmed diagnosis of advanced solid tumors.
Who cannot join
- Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
- Any other malignancy within 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of ZG005 in Patients With Advanced Solid Tumors
This is an open-label, multicenter, Phase II clinical trial, designed to evaluate the efficacy and safety of ZG005 in patients with advanced solid tumors who have previously failed or are intolerant to standard treatment.
- Conditions
- Advanced Solid Tumor
- Being tested
- ZG005 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG005 for InjectionBiological
Also called ZG005
Recommended Phase 2 Dose (RP2D) of ZG005(20 mg/kg), intravenous infusion, once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dose Expansion | Experimental | ZG005 dose expansion was performed in different tumors, such as: nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and other carcinoma Receives: Biological: ZG005 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
Measured: Up to 2 years
Secondary outcomes (1)
Adverse Event (AE)
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 posted15 Apr 2025
- Study start13 Jun 2025
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT06927687
- Sponsor's protocol ID
- ZG005-001-02
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2025
- Last updated
- 29 Apr 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of ZG005 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06927687
- Acronym / sponsor ID
- ZG005-001-02
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 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 is an open-label, multicenter, Phase II clinical trial, designed to evaluate the efficacy and safety of ZG005 in patients with advanced solid tumors who have previously failed or are intolerant to standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Expansion | Experimental | Biological: ZG005 for InjectionZG005 dose expansion was performed in different tumors, such as: nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and other carcinoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand the study and voluntarily sign the informed consent form.
- Male or female 18-75 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
- Life expectancy ≥ 12 weeks;
- Histologically or cytologically confirmed diagnosis of advanced solid tumors.
Key exclusion criteria (2 listed)
- Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
- Any other malignancy within 5 years.
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 |
|---|---|---|
| ZG005 for InjectionAlso: ZG005Recommended Phase 2 Dose (RP2D) of ZG005(20 mg/kg), intravenous infusion, once every 3 weeks. | Biological | Dose Expansion |
Primary outcome
Objective response rate(ORR)
Time frame: Up to 2 years
1 secondary outcome
Adverse Event (AE)
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 29 Apr 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. This study is not recruiting at the moment.
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 2 study testing 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: Up to 2 years). 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 29 Apr 2026.