NCT07233850

A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, phase II clinical trial evaluating the combination of SSGJ-706 with standard therapy for advanced gastrointestinal tumors. Its objective is to assess the safety, tolerability, and antitumor activity of SSGJ-706 in combination with standard treatment.

Detailed description

This multicohort, open-label, multicentre Phase II clinical trial is evaluating the use of SSGJ-706 in combination with standard first-line chemotherapy for advanced gastrointestinal tumours. The study comprises four cohorts: HER2-negative locally advanced gastric/gastro-oesophageal junction adenocarcinoma (Cohort A), metastatic colorectal cancer (Cohort B), locally advanced or metastatic pancreatic ductal adenocarcinoma (Cohort C), and locally advanced or metastatic oesophageal cancer (Cohort D). The primary objective of this study is to assess the safety and efficacy of SSGJ-706 when used in combination with standard first-line chemotherapy in participants with advanced or metastatic gastrointestinal tumours who have not previously received treatment in a metastatic setting.

Conditions

• Gastric/Gastroesophageal Junction Adenocarcinoma
• Metastatic Colorectal Cancer (CRC)
• Pancreatic Ductal Adenocarcinoma (PDAC)
• Oesophageal Cancer

Interventions

Type	Name	Description
DRUG	SSGJ-706+XELOX	SSGJ-706 (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, D1-D14, Q3W,up to 6 cycles) . Afterward, SSGJ-706 (administered on Day 1 of each cycle, Q3W) and Capecitabine (1000 mg/m2, p.o., Bid, D1-D14, Q3W) will be used for maintenance treatment.
DRUG	SSGJ-706+Bevacizumab+XELOX	SSGJ-706 (administered on Day 1 of each cycle, Q3W)+Bevacizumab (7.5 mg/kg intravenous infusion on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 8 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, D1-D14, Q3W,up to 8 cycles) . Afterward, SSGJ-706 (administered on Day 1 of each cycle, Q3W), Bevacizumab (7.5 mg/kg intravenous infusion on Day 1 of each cycle, Q3W) and Capecitabine (1000 mg/m2, p.o., Bid, D1-D14, Q3W) will be used for maintenance treatment.
DRUG	SSGJ-706+AG	SSGJ-706 (administered on Day 1 of each cycle, Q2W)+Albumin-bound Paclitaxel (125 mg/m2 intravenous infusion on Days 1, 8, 15 of each 28-day cycle)+ Gemcitabine(1000 mg/m2 intravenous infusion on Days 1, 8, 15 of each 28-day cycle) .
DRUG	SSGJ-706+TP	SSGJ-706 (administered on Day 1 of each cycle, Q3W)+Paclitaxel (175 mg/m2 intravenous infusion on Day 1, Q3W)+ Cisplatin(60-80 mg/m2 intravenous infusion on Day 1, Q3W) .

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: China