Solid TumorsPhase 1/2NCT06233292

A Study of ZG005 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing ZG005 Powder for Injection in people with Solid Tumors, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Solid Tumors
What is being tested?: ZG005 Powder for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteChina
Study dates: 17 Jun 2022to 22 Jul 2026
Phase: Phase 1/2
Are there results?: None posted in the registry

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 70 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 18-70 years of age;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
Life expectancy ≥ 3 months;
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.

China1 site

Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022

Other trials in China

About this study

Official title: A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors

Conditions: Solid Tumors
Being tested: ZG005 Powder for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZG005 Powder for InjectionBiological
Also called ZG005
The dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.
ZG005 Powder for InjectionBiological
Also called ZG005
Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.

Study groups in NCT06233292
Study group	Role	What they receive
Part 1: Dose Escalation	Experimental	The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD). Receives: Biological: ZG005 Powder for Injection
Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy	Experimental	The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma Receives: Biological: ZG005 Powder for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Limiting Toxicities (DLT)
A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause.
Measured: Up to 21Days
Adverse Event (AE)
Number of participants with adverse events that are related to treatment
Measured: Up to 24 Months
Objective Response Rate
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: Up to 24 Months
Maximum tolerated dose (MTD)
During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD.
Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 202222 Jul 2026

First posted31 Jan 2024
Study start17 Jun 2022
Primary completion22 Jul 2026
Study completion22 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorsStudies 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: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06233292
Sponsor's protocol ID: ZG005-001
Status last verified: Oct 2026
First submitted: 22 Jan 2024
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06233292
Acronym / sponsor ID: ZG005-001
Conditions: Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
Study start: 17 Jun 2022 (actual)
Primary completion: 22 Jul 2026 (actual)
Study completion: 22 Jul 2026 (actual)
First posted: 31 Jan 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part 1: Dose Escalation	Experimental	Biological: ZG005 Powder for InjectionThe study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).
Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy	Experimental	Biological: ZG005 Powder for InjectionThe dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma

Who may qualify

Ages: 18 to 70 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 18-70 years of age;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
Life expectancy ≥ 3 months;
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 Powder for InjectionAlso: ZG005The dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.	Biological	Part 1: Dose Escalation
ZG005 Powder for InjectionAlso: ZG005Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.	Biological	Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy

Primary outcome

Dose Limiting Toxicities (DLT)
Time frame: Up to 21Days
A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause.
Adverse Event (AE)
Time frame: Up to 24 Months
Number of participants with adverse events that are related to treatment
Objective Response Rate
Time frame: Up to 24 Months
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Maximum tolerated dose (MTD)
Time frame: Up to 24 Months
During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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 1/2 study testing ZG005 Powder for Injection in people with Solid Tumors, 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: finished, as of the sponsor's last update on 16 Oct 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose Limiting Toxicities (DLT) (time frame: Up to 21Days). 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?

On the ClinicalTrials.gov record for NCT06233292.

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 16 Oct 2026.