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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07016490




Registration number
NCT07016490
Ethics application status
Date submitted
28/05/2025
Date registered
11/06/2025
Date last updated
11/06/2025

Titles & IDs
Public title
A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors
Scientific title
A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SSGJ-709 in Patients With Advanced Malignant Tumors
Secondary ID [1] 0 0
SSGJ-709-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignant Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SSGJ-709

Experimental: Experimental: SSGJ-707 - 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.


Treatment: Drugs: SSGJ-709
A bispecific antibody targeting PD-1 and LAG-3.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of DLT
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [1] 0 0
Cmax of SSGJ-709
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [2] 0 0
Tmax of SSGJ-709
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [3] 0 0
AUC0-last of SSGJ-709
Timepoint [3] 0 0
through study completion, an average of 1 year
Secondary outcome [4] 0 0
Incidence of ADA
Timepoint [4] 0 0
through study completion, an average of 1 year
Secondary outcome [5] 0 0
ORR
Timepoint [5] 0 0
every 6 weeks after first dose, through study completion, an average of 1 year
Secondary outcome [6] 0 0
PFS assessed by investigator per RECIST v1.1
Timepoint [6] 0 0
through study completion, an average of 1 year

Eligibility
Key inclusion criteria
* 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;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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);
* 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:

1. 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);
2. 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;
3. Having received herbal medicine with an anti-tumor indication within 1 week prior to the first dose;
4. 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
6/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Southern Oncology Clinical Research Unit (SOCRU) - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shenyang Sunshine Pharmaceutical Co., LTD.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Macquarie University, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Parsonson
Address 0 0
Macquarie University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrew Parsonson
Address 0 0
Country 0 0
Phone 0 0
+61 2 9812 3538
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07016490