A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors

NCT07016490 | Recruiting Phase 1

• 1 other identifier: SSGJ-709-101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of DLT

  Dose limiting toxicity

  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.

  through study completion, an average of 1 year

Secondary Outcomes (6)

• Cmax of SSGJ-709

  through study completion, an average of 1 year

• Tmax of SSGJ-709

  through study completion, an average of 1 year

• AUC0-last of SSGJ-709

  through study completion, an average of 1 year

• Incidence of ADA

  through study completion, an average of 1 year

• ORR

  every 6 weeks after first dose, through study completion, an average of 1 year

Study Arms (1)

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.

Drug: SSGJ-709

Interventions

SSGJ-709 DRUG

A bispecific antibody targeting PD-1 and LAG-3.

Experimental: SSGJ-709

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead
• Macquarie University, Australia: collaborator

Study Sites (1)

Southern Oncology Clinical Research Unit (SOCRU)

Adelaide, Australia

RECRUITING

Study Officials

• Andrew Parsonson

  Macquarie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Parsonson

CONTACT

+61 2 9812 3538; andrew.parsonson@mqhealth.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 11, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)