Advanced Malignant TumorsPhase 1NCT07016490
A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors
A Phase 1 study testing SSGJ-709 in people with Advanced Malignant Tumors, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in Australia.
Trial summary
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and anti-tumor activity of SSGJ-709 as a single agent in patients with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- SSGJ-709
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Jun 2025to 30 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum life expectancy of 3 months;
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0-1;
- Locally advanced or metastatic malignant tumors confirmed by histopathology or cytology; preferred tumor types for enrollment include head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma or adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, urothelial carcinoma, and clear cell renal cell carcinoma. Subjects with other tumor types may be enrolled after discussion with the sponsor；
- Subject who have failed, or has been intolerant to standard therapy, or has been considered lack standard of care for a given tumor type, and who is not able to complete surgical resection and receive curative concurrent/sequential chemoradiotherapy；
- Having at least one measurable tumor lesion as the target lesion assessed per RECIST v1.1；
- The subject has adequate hematological and organ functions；
Who cannot join
- Presence of brainstem, meningeal metastases, spinal cord metastases or compression；
- Presence of active central nervous system (CNS) metastases；
- Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require repeated drainage；
- Subjects with other malignant tumors within 3 years prior to screening；
- Subjects with autoimmune diseases that require systemic treatment within 2 years before screening；
- Subjects are positive for human immunodeficiency virus (HIV)；
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- Prior or current presence of non-infectious pneumonia/interstitial lung disease requiring systemic therapy with glucocorticoids；
- Serious infection within 4 weeks prior to the first dose or the presence of any active infection requiring systemic anti-infective therapy.
- Having received the following treatments prior to the first dose of study treatment:
- Having received anti-tumor therapies such as biological agents, chemotherapy and other investigational drugs not approved for marketing within 3 weeks prior to the first dose of study treatment (Patient may be enrolled if the first dose of study treatment is more than 5 half-lives of the drug from the last anti-tumor therapy);
- Having received small molecule targeted antineoplastic agents (e.g., tyrosine kinase inhibitor), or palliative local therapy for non-target lesions, or non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor) within 2 weeks prior to the first dose;
- Having received herbal medicine with an anti-tumor indication within 1 week prior to the first dose;
- Prior immunotherapy other than anti-PD-(L)1 therapy (Patients with prior immunotherapy against other targets may be enrolled after discussion and agreement with the sponsor).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Southern Oncology Clinical Research Unit (SOCRU)
Adelaide
Nazim Abbas, +61 491 679 039, nazim.abbas@socru.org.au
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SSGJ-709 in Patients With Advanced Malignant Tumors
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and anti-tumor activity of SSGJ-709 as a single agent in patients with advanced malignancies.
Read the detailed description
The goal of this clinical trial is to learn more about a new drug called SSGJ-709 . The primary aim of this clinical trial is to test the safety of SSGJ-709 at different dose levels on patients with advanced malignant tumors. The clinical trial consists of two phases. The dose escalation phase involves the process of gradually increasing the amount of drug given to find the highest dose that is safe and effective. The dose expansion phase involves the process of giving a drug at a specific dose to a larger group of participants to further evaluate its safety and effectiveness.
Participants will:
- Receive SSGJ-709 infusion once every 3 weeks
- Visit the clinic once every 3 weeks for checkups and tests
- Conditions
- Advanced Malignant Tumors
- Being tested
- SSGJ-709
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-709Drug
A bispecific antibody targeting PD-1 and LAG-3.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: SSGJ-709 | Experimental | In dose escalation phase, SSGJ-709 will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 5 levels, Q3W IV. During or after dose escalation, any dose level that does not exceed the MTD can be expanded. Receives: Drug: SSGJ-709 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT
Dose limiting toxicity
Measured: 21 days
Incidence of Treatment-Emergent Adverse Events
TEAE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Cmax of SSGJ-709
Peak Plasma Concentration
Measured: through study completion, an average of 1 year
Tmax of SSGJ-709
Time to peak drug concentration
Measured: through study completion, an average of 1 year
AUC0-last of SSGJ-709
the area under the curve (AUC) up to the last measurable concentration
Measured: through study completion, an average of 1 year
Incidence of ADA
Number of subjects with detectable anti-drug antibodies (ADA)
Measured: through study completion, an average of 1 year
ORR
ORR ( objective response rate) is the proportion of subjects with complete response(CR) or partial response(PR), evaluated by the investigators per RECIST v1.1
Measured: every 6 weeks after first dose, through study completion, an average of 1 year
PFS assessed by investigator per RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
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 posted11 Jun 2025
- Study start12 Jun 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Macquarie University, Australia
- Responsible party
- Sponsor
- Investigators
- Andrew Parsonson, Principal investigator, Macquarie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016490
- Sponsor's protocol ID
- SSGJ-709-101
- Status last verified
- Jan 2026
- First submitted
- 28 May 2025
- Last updated
- 28 Jan 2026
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SSGJ-709 in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07016490
- Acronym / sponsor ID
- SSGJ-709-101
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Macquarie University, Australia
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 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 anti-tumor activity of SSGJ-709 as a single agent in patients with advanced malignancies.
Detailed description
The goal of this clinical trial is to learn more about a new drug called SSGJ-709 . The primary aim of this clinical trial is to test the safety of SSGJ-709 at different dose levels on patients with advanced malignant tumors. The clinical trial consists of two phases. The dose escalation phase involves the process of gradually increasing the amount of drug given to find the highest dose that is safe and effective. The dose expansion phase involves the process of giving a drug at a specific dose to a larger group of participants to further evaluate its safety and effectiveness.
Participants will:
- Receive SSGJ-709 infusion once every 3 weeks
- Visit the clinic once every 3 weeks for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: SSGJ-709 | Experimental | Drug: SSGJ-709In dose escalation phase, SSGJ-709 will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 5 levels, Q3W IV. During or after dose escalation, any dose level that does not exceed the MTD can be expanded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum life expectancy of 3 months;
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0-1;
- Locally advanced or metastatic malignant tumors confirmed by histopathology or cytology; preferred tumor types for enrollment include head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma or adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, urothelial carcinoma, and clear cell renal cell carcinoma. Subjects with other tumor types may be enrolled after discussion with the sponsor；
- Subject who have failed, or has been intolerant to standard therapy, or has been considered lack standard of care for a given tumor type, and who is not able to complete surgical resection and receive curative concurrent/sequential chemoradiotherapy；
- Having at least one measurable tumor lesion as the target lesion assessed per RECIST v1.1；
Key exclusion criteria (13 listed)
- Presence of brainstem, meningeal metastases, spinal cord metastases or compression；
- Presence of active central nervous system (CNS) metastases；
- Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require repeated drainage；
- Subjects with other malignant tumors within 3 years prior to screening；
- Subjects with autoimmune diseases that require systemic treatment within 2 years before screening；
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-709A bispecific antibody targeting PD-1 and LAG-3. | Drug | Experimental: SSGJ-709 |
Primary outcome
Incidence of DLT
Time frame: 21 days
Dose limiting toxicity
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, an average of 1 year
TEAE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
6 secondary outcomes
Cmax of SSGJ-709
Time frame: through study completion, an average of 1 year
Tmax of SSGJ-709
Time frame: through study completion, an average of 1 year
AUC0-last of SSGJ-709
Time frame: through study completion, an average of 1 year
Incidence of ADA
Time frame: through study completion, an average of 1 year
ORR
Time frame: every 6 weeks after first dose, through study completion, an average of 1 year
PFS assessed by investigator per RECIST v1.1
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 28 Jan 2026.
- 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.
Andrew Parsonson principal investigator
Macquarie University
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-709 in people with Advanced Malignant Tumors, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in Australia.
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 6 inclusion and 13 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 28 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 Australia. 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 Andrew Parsonson (+61 2 9812 3538, andrew.parsonson@mqhealth.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT (time frame: 21 days). 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 28 Jan 2026.