A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients

Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ID
NCT06493760
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • SSGJ-707 — DRUG
    bispecific antibody
  • Bevacizumab — DRUG
    VEGF antibody
  • Oxaliplatin — DRUG
    chemotherapy
  • Capecitabine — DRUG
    chemotherapy
  • Calcium Folinate — DRUG
    chemotherapy
  • 5-fluorouracil — DRUG
    chemotherapy

Study Details

This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2: SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.

Key Dates

Start date
Sep 3, 2024
Status verified
Sep 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SSGJ-707(dose 1)+ XELOX
  • Experimental: SSGJ-707(dose 1)+ mFOLFOX6
  • Experimental: SSGJ-707(dose 2)+ XELOX
  • Experimental: SSGJ-707(dose 2)+ mFOLFOX6
  • Experimental: SSGJ-707+XELOX/mFOLFOX6
  • Active Comparator: Bevacizumab+XELOX/mFOLFOX6
  • Experimental: SSGJ-707 monotherapy

Primary Outcome Measure

ORR [ Time Frame: 12 months ]

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