NCT06390774

A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.

Detailed description

This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).

Conditions

• Locally Advanced, Recurrent or Metastatic Malignancies

Interventions

Type	Name	Description
DRUG	SSGJ-705	anti-PD-1 and anti-HER2 bispecific antibody

Timeline

• Start date: 2024-05-30
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2024-04-30
• Last updated: 2024-10-18

Locations

1 site across 1 country: China