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Recruiting NCT06493760

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

Phase II Interventional Metastatic Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SSGJ-707, Bevacizumab, Oxaliplatin, Capecitabine.
Who it may be relevant to
Registry conditions: Metastatic Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients

Overview

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.

Interventions

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

Primary outcome measures

  • ORR [Time frame: 12 months]
  • Safety and tolerability [Time frame: 12 months]
Secondary outcome measures (1)
  • PFS [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Males and/or females over age 18
  • Histologically and/or cytologically documented metastatic colorectal cancer confirmed .
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Expected survival >=12 weeks.
  • Signed informed consent form.

Exclusion criteria

  • Known uncontrolled or symptomatic central nervous system metastatic disease.
  • Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
  • Inadequate organ or bone marrow function.
  • Pregnant or breast-feeding woman.
  • Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Liu Tianshu — Shanghai

Identifiers

NCT: NCT06493760 · SSGJ-707-CRC-II-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗