NCT07016490

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Malignant Tumors

Interventions

Type	Name	Description
DRUG	SSGJ-709	A bispecific antibody targeting PD-1 and LAG-3.

Timeline

• Start date: 2025-06-12
• Primary completion: 2027-09-30
• Completion: 2027-12-30
• First posted: 2025-06-11
• Last updated: 2026-01-28

Locations

1 site across 1 country: Australia