Advanced Malignant TumorsPhase 1NCT07032298
A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors
A Phase 1 study testing SSGJ-612 in people with Advanced Malignant Tumors, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- SSGJ-612
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2025to Jun 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form;
- Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender;
- Expected survival ≥3 months;
- Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
- Patients with pathologically or cytologically confirmed locally advanced or metastatic malignant tumors who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment available, and cannot undergo complete surgical resection or receive radical concurrent/sequential chemoradiotherapy;
- Tumor tissue with HER2 expression;
- At least one measurable tumor lesion assessed as the target lesion according to RECIST v1.1 criteria, and the lesion is suitable for repeated and accurate measurement.
Who cannot join
- Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression;
- Presence of active central nervous system (CNS) metastatic lesions;
- Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites;
- Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test;
- Known active tuberculosis; known active syphilis infection;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
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- Use of any live vaccine or attenuated live vaccine within 4 weeks before the first dose, or plan to receive any live vaccine or attenuated live vaccine during the study;
- Known severe allergic history to any component of the investigational drug, or history of severe allergic reaction to antibodies;
- Pregnant or lactating women.
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
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
Jun Yao, M.D., 13663790098, yaojun74@163.com
Cai'e Wang, M.D., 13837915297, 2454544618@qq.com
About this study
Official title: Phase I Clinical Study on the Safety, Pharmacokinetics and Antitumor Activity of SSGJ-612 in Patients With Advanced Solid Tumors
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.
Read the detailed description
The clinical trial consists of two phases. In the dose escalation stage, the accelerated titration method combined with the traditional "3+3" design will be adopted, to evaluate the safety and dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) or the maximum dose of administration (MAD). In the dose expansion phase, several safe and effective dose levels of SSGJ-612 will be expanded and further evaluated in larger groups of participants.
- Conditions
- Advanced Malignant Tumors
- Being tested
- SSGJ-612
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-612Drug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-612 | Experimental | In dose escalation phase, participants will receive one of the five increasing dose levels of SSGJ-612 respectively, intravenously (IV). During or after dose escalation, any dose levels that does not exceed the MTD can be expanded. Receives: Drug: SSGJ-612 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events (AEs)
Adverse Events (AEs) refers to all adverse medical events that occur in patients after they receive the investigational drug and do not necessarily have a causal relationship with the investigational drug. AEs were evaluated according to CTCAE V5.0.
Measured: Through study completion, an average of 1 year
Incidence of DLT
Dose-Limiting Toxicity
Measured: 14 days
Secondary outcomes (13)
ORR assessed by investigators per RECIST v1.1
Objective Response Rate (ORR) is the proportion of patients with Complete Response (CR) or Partial Response (PR), assessed by investigators per RECIST v1.1.
Measured: Through study completion, an average of 1 year
DoR assessed by investigators per RECIST v1.1
Duration of Response (DoR) is the time between the first onset of CR or PR and the first onset of Disease Progression (PD) (assessed by investigators per RECIST v1.1) or death from any cause.
Measured: Through study completion, an average of 1 year
DCR assessed by investigators per RECIST v1.1
Disease Control Rate (DCR) is the proportion of patients with CR, PR, and Stable Disease (SD), assessed by investigators per RECIST v1.1.
Measured: Through study completion, an average of 1 year
TTR assessed by investigators per RECIST v1.1
Time to Response (TTR) is the time from the start of treatment until the date of first documented response (assessed by investigators per RECIST v1.1).
Measured: Through study completion, an average of 1 year
PFS
Progression-Free Survival (PFS) is the time between first initiation of study treatment to PD (assessed by investigators per RECIST v1.1) or death due to any reason.
Measured: Through study completion, an average of 1 year
OS
Overall Survival (OS) is defined as the time from the start of treatment with SSGJ-612 until death due to any cause.
Measured: Through study completion, an average of 1 year
Cmax of SSGJ-612
Peak concentration (Cmax), in single dose period and multiple dose periods.
Measured: Through study completion, an average of 1 year
Cmin of SSGJ-612
Trough concentration (Cmin), in multiple dose periods.
Measured: Through study completion, an average of 1 year
Tmax of SSGJ-612
Peak time (Tmax), in single dose period and multiple dose periods.
Measured: Through study completion, an average of 1 year
T1/2 of SSGJ-612
Elimination phase half-life (T1/2), in single dose period and multiple dose periods.
Measured: Through study completion, an average of 1 year
AUC0-last
Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t), in single dose period and multiple dose periods.
Measured: Through study completion, an average of 1 year
Incidence of ADA and Nab
Number of patients with detectable Anti-drug Antibody (ADA) and Neutralizing Antibodies (NAb).
Measured: Through study completion, an average of 1 year
The correlation between HER2 expression and efficacy
The correlation between expression level of HER2 in tumor tissues and anti-tumor activity.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2025
- Study start18 Jul 2025
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032298
- Sponsor's protocol ID
- SSGJ-612-101
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Safety, Pharmacokinetics and Antitumor Activity of SSGJ-612 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07032298
- Acronym / sponsor ID
- SSGJ-612-101
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Jun 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 phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.
Detailed description
The clinical trial consists of two phases. In the dose escalation stage, the accelerated titration method combined with the traditional "3+3" design will be adopted, to evaluate the safety and dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) or the maximum dose of administration (MAD). In the dose expansion phase, several safe and effective dose levels of SSGJ-612 will be expanded and further evaluated in larger groups of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SSGJ-612 | Experimental | Drug: SSGJ-612In dose escalation phase, participants will receive one of the five increasing dose levels of SSGJ-612 respectively, intravenously (IV). During or after dose escalation, any dose levels that does not exceed the MTD can be expanded. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form;
- Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender;
- Expected survival ≥3 months;
- Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
- Patients with pathologically or cytologically confirmed locally advanced or metastatic malignant tumors who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment available, and cannot undergo complete surgical resection or receive radical concurrent/sequential chemoradiotherapy;
Key exclusion criteria (9 listed)
- Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression;
- Presence of active central nervous system (CNS) metastatic lesions;
- Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites;
- Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test;
- Known active tuberculosis; known active syphilis infection;
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 |
|---|---|---|
| SSGJ-612Intravenous injection | Drug | SSGJ-612 |
Primary outcome
Incidence and severity of Adverse Events (AEs)
Time frame: Through study completion, an average of 1 year
Adverse Events (AEs) refers to all adverse medical events that occur in patients after they receive the investigational drug and do not necessarily have a causal relationship with the investigational drug. AEs were evaluated according to CTCAE V5.0.
Incidence of DLT
Time frame: 14 days
Dose-Limiting Toxicity
13 secondary outcomes
ORR assessed by investigators per RECIST v1.1
Time frame: Through study completion, an average of 1 year
DoR assessed by investigators per RECIST v1.1
Time frame: Through study completion, an average of 1 year
DCR assessed by investigators per RECIST v1.1
Time frame: Through study completion, an average of 1 year
TTR assessed by investigators per RECIST v1.1
Time frame: Through study completion, an average of 1 year
PFS
Time frame: Through study completion, an average of 1 year
OS
Time frame: Through study completion, an average of 1 year
Cmax of SSGJ-612
Time frame: Through study completion, an average of 1 year
Cmin of SSGJ-612
Time frame: Through study completion, an average of 1 year
Tmax of SSGJ-612
Time frame: Through study completion, an average of 1 year
T1/2 of SSGJ-612
Time frame: Through study completion, an average of 1 year
AUC0-last
Time frame: Through study completion, an average of 1 year
Incidence of ADA and Nab
Time frame: Through study completion, an average of 1 year
The correlation between HER2 expression and efficacy
Time frame: Through study completion, an average of 1 year
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 25 Jul 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.
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 SSGJ-612 in people with Advanced Malignant Tumors, run by Shenyang Sunshine Pharmaceutical 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 7 inclusion and 9 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 25 Jul 2025. 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?
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 Jun Yao, M.D. (13663790098, yaojun74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) (time frame: Through study completion, an average of 1 year). 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 25 Jul 2025.