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NCT Number: NCT06493760

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

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.

Recruiting

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liu Tianshu

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Liu Tianshu, PhD

CONTACT

[email protected]

13681973996

Liu Tianshu, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSGJ-707

Drug

bispecific antibody

Bevacizumab

Drug

VEGF antibody

Oxaliplatin

Drug

chemotherapy

Capecitabine

Drug

chemotherapy

Calcium folinate

Drug

chemotherapy

5-fluorouracil

Drug

chemotherapy

Primary outcomes

  1. ORR

    Time frame: 12 months

    Objective response rate

  2. Safety and tolerability

    Time frame: 12 months

    Safety and tolerability assessed by incidence and severity of adverse events

Secondary outcomes

  1. PFS

    Time frame: 24 months

    The efficacy end points

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jul 10, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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