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A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SSGJ-709 in Patients With Advanced Malignant Tumors

NCT07016490•Shenyang Sunshine Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

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.

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: 1. Receive SSGJ-709 infusion once every 3 weeks 2. Visit the clinic once every 3 weeks for checkups and tests

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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；

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);
+3 more criteria

Locations (1)

Southern Oncology Clinical Research Unit (SOCRU)

Adelaide, Australia

Key Dates

Start Date

June 12, 2025

Primary Completion Date

September 30, 2027

Completion Date

December 30, 2027

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Malignant Tumors

Interventions

SSGJ-709

DRUG

Contacts

Andrew Parsonson

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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