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

Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Study ID
NCT07233850
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SSGJ-706+XELOX — DRUG
    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.
  • SSGJ-706+Bevacizumab+XELOX — DRUG
    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.
  • SSGJ-706+AG — DRUG
    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) .
  • SSGJ-706+TP — DRUG
    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) .

Study Details

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.

Key Dates

First listed
Nov 18, 2025
Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
  • Experimental: Cohort B
  • Experimental: Cohort C
  • Experimental: Cohort D

Primary Outcome Measure

Incidence and severity of Adverse Events [ Time Frame: 12 months ]

Central Contacts

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