Advanced Solid TumorsPhase 1NCT05864573
Study of ZGGS15 in Patients With Advanced Solid Tumors
A Phase 1 study testing ZGGS15 in people with Advanced Solid Tumors, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This is a multi-center, open-label, Phase 1 clinical study of ZGGS15 for the treatment of patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- ZGGS15
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2023to 26 Jun 2025
- Phase
- Phase 1
- 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;
- Histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom the available standard treatments failed;
- Must have at least 1 measurable lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Life expectancy ≥ 3 months;
- All adverse events from prior treatment have either returned to baseline or CTCAE v5.0≤Grade 1;
- Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.
Who cannot join
- Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of the central nervous system (CNS) metastases；
- Uncontrollable third cavity effusion requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
- The main organ function meets any of the following criteria within 7 days prior to treatment:
- Hematological function: absolute neutrophil count (ANC) < 1.5 × 10^9/L, platelet (PLT) < 75 × 10^9/L, or hemoglobin (Hb) < 100 g/L;
- Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), ALT and AST ≥ 5×ULN for patients with liver metastases; total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30 g/L;
- Blood cholesterol > 300 mg/dL or > 7.75 mmol/L;
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- Creatinine clearance (Cockcroft-Gault formula) < 50 mL/min;
- International normalized ratio (INR) > 1.5 or activated partial thromboplastin time (APTT) > 1.5×ULN;
- Any other malignancy within 5 years;
- Abnormal thyroid function with clinical symptoms or diabetes, which cannot be controlled by available treatments;
- History of autoimmune disease, including but not limited to systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis;
- Previous immune checkpoint inhibitors induced ≥ Grade 2 immune-related adverse reactions in vital organs, including but not limited to myocarditis and central nervous system toxicity; rapidly tumor progressed after previous PD-1 inhibitor treatment;
- Interstitial lung disease, non-infectious pneumonitis, and radiation-induced pneumonia with symptoms and/or requiring steroids for treatment;
- Received prior allogeneic stem cell transplantation or solid organ transplantation;
- Active infection within 1 week before the first administration currently requires systemic anti-infective therapy;
- Known allergy to other mAbs or any antibody excipient, severe allergic reaction to humanized antibodies or fusion proteins, and history of anaphylactoid reaction or other hypersensitivity reactions;
- Known history of diagnosed neurological or mental disorders, for example, epilepsy, dementia, etc.;
- Patients were deemed unsuitable for participating in the study by the investigator for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZGGS15 in Patients With Advanced Solid Tumors
This is a multi-center, open-label, Phase 1 clinical study of ZGGS15 for the treatment of patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- ZGGS15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZGGS15Biological
ZGGS15 for dose escalations are set as 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg, intravenous infusion, once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ZGGS15 | Experimental | Not described Receives: Biological: ZGGS15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicities (DLTs)
A DLT is defined as any of the following adverse events occurring from the first dose to the end of the first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progression or definitely due to an external cause.
Measured: Up to 21Days
The maximum tolerated dose (MTD)
During the dose-escalation stage, if ≥ 2 patients in a dose group experienced DLTs, then the dose level will be considered to be an intolerable dose, and the previous lower dose will be considered to be the MTD.
Measured: Up to 24 Months
The recommended dose for subsequent study
The recommended dose for the subsequent study will be based on the data of preliminary efficacy, safety, PK, receptor occupancy results and biomarker (for example, immune activation), etc. from the dose-escalation phase, and will be fully evaluated among the investigators and the sponsor. The recommended dose for subsequent study should have at least 6 evaluable patients.
Measured: Up to 24 Months
Secondary outcomes (3)
Objective Response Rate (ORR)
Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Measured: Up to 24 Months
Duration of response (DOR)
Objective Response Rate will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Measured: Up to 24 Months
Disease control rate (DCR)
Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
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.
- First posted18 May 2023
- Study start19 Jul 2023
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji Zhu, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864573
- Sponsor's protocol ID
- ZGGS15-001
- Status last verified
- Dec 2025
- First submitted
- 8 May 2023
- 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 1 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZGGS15 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05864573
- Acronym / sponsor ID
- ZGGS15-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 18 May 2023 (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 a multi-center, open-label, Phase 1 clinical study of ZGGS15 for the treatment of patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZGGS15 | Experimental | Biological: ZGGS15 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understand the study and voluntarily sign the informed consent form;
- Male or female, 18-70 years of age;
- Histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom the available standard treatments failed;
- Must have at least 1 measurable lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
Key exclusion criteria (18 listed)
- Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of the central nervous system (CNS) metastases；
- Uncontrollable third cavity effusion requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
- The main organ function meets any of the following criteria within 7 days prior to treatment:
- Any other malignancy within 5 years;
- Abnormal thyroid function with clinical symptoms or diabetes, which cannot be controlled by available treatments;
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 |
|---|---|---|
| ZGGS15ZGGS15 for dose escalations are set as 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg, intravenous infusion, once every 3 weeks. | Biological | ZGGS15 |
Primary outcome
The incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 21Days
A DLT is defined as any of the following adverse events occurring from the first dose to the end of the first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progression or definitely due to an external cause.
The maximum tolerated dose (MTD)
Time frame: Up to 24 Months
During the dose-escalation stage, if ≥ 2 patients in a dose group experienced DLTs, then the dose level will be considered to be an intolerable dose, and the previous lower dose will be considered to be the MTD.
The recommended dose for subsequent study
Time frame: Up to 24 Months
The recommended dose for the subsequent study will be based on the data of preliminary efficacy, safety, PK, receptor occupancy results and biomarker (for example, immune activation), etc. from the dose-escalation phase, and will be fully evaluated among the investigators and the sponsor. The recommended dose for subsequent study should have at least 6 evaluable patients.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 Months
Duration of response (DOR)
Time frame: Up to 24 Months
Disease control rate (DCR)
Time frame: Up to 24 Months
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 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. This study is not recruiting at the moment.
Ji Zhu principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZGGS15 in people with Advanced 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 8 inclusion and 18 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 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 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.
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?
The incidence of dose-limiting toxicities (DLTs) (time frame: Up to 21Days). The study lists 3 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.