Locally Advanced/Metastatic Solid TumorsPhase 1NCT06979674
Study of ESG406 in Adults With Solid Tumors
A Phase 1 study testing ESG406 in people with Locally Advanced/Metastatic Solid Tumors, run by Shanghai Escugen Biotechnology Co., Ltd at 3 sites in China.
Trial summary
This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced/Metastatic Solid Tumors
- What is being tested?
- ESG406
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 3 sitesChina
- Study dates
- 4 Jun 2025to Jun 2028
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 to 80 years.
- Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- At least one measurable lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Adequate organ and bone marrow function.
- Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last investigational product administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause.
Who cannot join
- Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational product administration.
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
- Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.
- Use of any investigational anti-cancer drug within 4 weeks or 5 half-lives before the first investigational product administration.
- A history of thromboembolic or cerebrovascular events within 6 months prior to the first dose of the investigational drug.
- History of (noninfectious) interstitial pneumonia (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or suspected ILD/noninfectious pneumonitis at screening.
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- Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.
- Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.
- Patients with uncontrollable systemic diseases.
- Subjects with clinically significant cardiovascular disease.
- Human Immunodeficiency Virus (HIV) infection.
- Active hepatitis B or hepatitis C.
- Have an allergic constitution, or to be allergic to any investigational drug or excipient ingredient.
- Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Yongsheng Li, PhD
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Fuming Qiu, PhD
- Recruiting
The First Affiliated Hospital of Xi 'An Jiaotong University
Xi’an, Shanxi, 710061
Ruifang An, PhD
About this study
Official title: An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG406 in Subjects With Locally Advanced/Metastatic Solid Tumors
This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- Being tested
- ESG406
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESG406Drug
Administered via intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| ESG406 for injection | Experimental | The dosage is calculated based on the weight of the subjects and the corresponding dose group. Subjects will receive treatment until disease progression, or starts a new tumor treatment, or stops taking medication for other reasons. Receives: Drug: ESG406 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious:
Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: First dose date up to last dose plus 30 days
Secondary outcomes (6)
Objective Response Rate
Objective Response Rate(ORR) is defined as the rate an overall best response of either complete response (CR) or partial response (PR) .
Measured: Up to approximately 36 months.
Progression Free Survival
Progression-free survival (PFS) is defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
Measured: Up to approximately 36 months.
Cmax
Maximum observed plasma concentration
Measured: Up to approximately 36 months.
AUC0-inf
Area under the serum concentration time curve from time 0 extrapolated to infinity
Measured: Up to approximately 36 months.
T1/2
Half-life
Measured: Up to approximately 36 months.
Anti-drug Antibodies
Incidence of anti-drug antibodies
Measured: Up to approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start4 Jun 2025
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced/Metastatic Solid TumorsStudies of the same condition, open and under way.
- 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
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Escugen Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fuming Qiu, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979674
- Sponsor's protocol ID
- ESG406-101
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 12 Sep 2025
- Results posted
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG406 in Subjects With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06979674
- Acronym / sponsor ID
- ESG406-101
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Shanghai Escugen Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 May 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 study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESG406 for injection | Experimental | Drug: ESG406The dosage is calculated based on the weight of the subjects and the corresponding dose group. Subjects will receive treatment until disease progression, or starts a new tumor treatment, or stops taking medication for other reasons. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged 18 to 80 years.
- Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- At least one measurable lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
Key exclusion criteria (14 listed)
- Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational product administration.
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
- Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.
- Use of any investigational anti-cancer drug within 4 weeks or 5 half-lives before the first investigational product administration.
- A history of thromboembolic or cerebrovascular events within 6 months prior to the first dose of the investigational drug.
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 |
|---|---|---|
| ESG406Administered via intravenous (IV) infusion. | Drug | ESG406 for injection |
Primary outcome
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Time frame: First dose date up to last dose plus 30 days
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
6 secondary outcomes
Objective Response Rate
Time frame: Up to approximately 36 months.
Progression Free Survival
Time frame: Up to approximately 36 months.
Cmax
Time frame: Up to approximately 36 months.
AUC0-inf
Time frame: Up to approximately 36 months.
T1/2
Time frame: Up to approximately 36 months.
Anti-drug Antibodies
Time frame: Up to approximately 36 months.
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 12 Sep 2025.
- 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.
Fuming Qiu, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ESG406 in people with Locally Advanced/Metastatic Solid Tumors, run by Shanghai Escugen Biotechnology Co., Ltd at 3 sites 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 7 inclusion and 14 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Xiaoyan Xing, PhD (+86 21 5855 6098, xingxiaoyan@escugen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events (time frame: First dose date up to last dose plus 30 days). 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 12 Sep 2025.