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

NCT07233850 | Not Yet Recruiting Phase 2

• 1 other identifier: SSGJ-706-202
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of Adverse Events

  12 months

• Objective response rate (ORR)

  12 months

Secondary Outcomes (5)

• DCR : Disease Control Rate

  12 months

• PFS：Progression-Free Survival

  24 months

• OS：Overall Survival

  24 months

• The blood concentration of SSGJ-706

  Approximately 6 months

• The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)

  Approximately 6 months

Study Arms (4)

Cohort A

EXPERIMENTAL

Drug: SSGJ-706+XELOX

Cohort B

EXPERIMENTAL

Drug: SSGJ-706+Bevacizumab+XELOX

Cohort C

EXPERIMENTAL

Drug: SSGJ-706+AG

Cohort D

EXPERIMENTAL

Drug: SSGJ-706+TP

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.

Also known as: Oxaliplatin, Capecitabine

Cohort A

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.

Cohort B

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) .

Cohort C

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) .

Cohort D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in this study, willing to follow all trial procedures, and sign the informed consent form (ICF).
• Age 18-75 years old, male or female.
• Has a life expectancy of at least 3 months
• ECOG score of 0-1.
• Locally advanced or metastatic tumors of the digestive system that cannot be curatively resected and cannot be treated with radical chemoradiotherapy, including gastric/gastroesophageal junction adenocarcinoma, colorectal cancer, pancreatic ductal adenocarcinoma, and oesophageal cancer.
• No prior systemic therapy in the locally advanced unresectable/metastatic setting.
• Has at least 1 measurable lesion per RECIST version 1.1.
• Willing to provide a paraffin-embedded (FFPE) specimen or an unstained histopathological section (preferably a newly obtained tumor tissue sample).
• Has bone marrow, kidney, liver, blood and clotting test results required per protocol.
• Female subjects of childbearing age had a negative serum pregnancy test within 7 days before the first dose. Male and female subjects of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until at least 120 days after the last use of study drug and for at least 180 days after the last use of chemotherapy drugs or bevacizumab. During this period, women are not lactating, male subjects are not allowed to freeze or donate sperm, and female subjects are not allowed to donate eggs or retrieve eggs for personal use.

You may not qualify if:

• For gastric/gastroesophageal junction adenocarcinoma: HER2-positive (defined as IHC 3+, or IHC 2+ with ISH-positive).
• For colorectal cancer: Patients with known MSI-H or dMMR.
• Presence of brainstem, meningeal metastases, spinal cord metastases, or compression.
• Presence of active central nervous system (CNS) metastases; Subjects with previously treated brain metastases (such as surgery, radiotherapy) are allowed to enroll if they are clinically stable for at least four weeks after treatment (until the first dose of study drug) and corticosteroids are discontinued 3 days before the first dose of study drug; Subjects with untreated, asymptomatic brain metastases can be enrolled.
• Previous immunotherapy, including immune checkpoint inhibitors (e.g., PD-l/L1 antibody, anti-CTLA-4 antibody, anti-TIGIT antibody, anti-LAG3 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, OX40 antibody, etc.), immune cell therapy and any other treatment targeting the mechanism of anti-tumor immune action.
• Adverse reactions caused by previous anti-tumor therapy need to be restored to grade ≤1 (as judged by NCI-CTCAE 5.0 criteria), except for alopecia and fatigue.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Prior or current non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy.
• History of severe bleeding tendency or coagulation dysfunction.
• Presence of gastrointestinal perforation and/or fistula, intra-abdominal abscess within 6 months before the first dose.
• Subjects with known active tuberculosis (TB).
• Known history of severe allergy to any component of the trial drug, or history of severe allergic reaction to chimeric or humanized antibodies.
• Other conditions that, in the opinion of the investigator, may increase study-related risks or interfere with the interpretation of study results.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Esophageal Neoplasms

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

xianglin yuan, MD

CONTACT

13667241722; octtongji@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)