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

A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 as First-Line Treatment 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: SSGJ-707; Drug: Oxaliplatin; Drug: Calcium Folinate; Drug: 5-fluorouracil; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Liu Tianshu
      • Contact: Liu Tianshu, PhD; Phone Number: 13681973996; Email: liu.tianshu@zs-hospital.sh.cn
      • Principal Investigator: Liu Tianshu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. 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).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSGJ-707(dose 1)+ XELOX	Drug: Capecitabine; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: Oxaliplatin; chemotherapy
Experimental: SSGJ-707(dose 1)+ mFOLFOX6	Drug: SSGJ-707; bispecific antibody; Drug: Oxaliplatin; chemotherapy; Drug: Calcium Folinate; chemotherapy; Drug: 5-fluorouracil; chemotherapy
Experimental: SSGJ-707(dose 2)+ XELOX	Drug: Capecitabine; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: Oxaliplatin; chemotherapy
Experimental: SSGJ-707(dose 2)+ mFOLFOX6	Drug: SSGJ-707; bispecific antibody; Drug: Oxaliplatin; chemotherapy; Drug: Calcium Folinate; chemotherapy; Drug: 5-fluorouracil; chemotherapy
Experimental: SSGJ-707+XELOX/mFOLFOX6	Drug: Capecitabine; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: Oxaliplatin; chemotherapy; Drug: Calcium Folinate; chemotherapy; Drug: 5-fluorouracil; chemotherapy
Active Comparator: Bevacizumab+XELOX/mFOLFOX6	Drug: Capecitabine; chemotherapy; Drug: Oxaliplatin; chemotherapy; Drug: Calcium Folinate; chemotherapy; Drug: 5-fluorouracil; chemotherapy; Drug: Bevacizumab; VEGF antibody
Experimental: SSGJ-707 monotherapy	Drug: SSGJ-707; bispecific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate	12 months
Safety and tolerability	Safety and tolerability assessed by incidence and severity of adverse events	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	The efficacy end points	24 months

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: colorectal cancer; SSGJ-707
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Micronutrients; Vitamins; Calcium-Regulating Hormones and Agents; Antidotes; Vitamin B Complex; Fluorouracil; Capecitabine; Oxaliplatin; Bevacizumab; Leucovorin; Calcium; Levoleucovorin
• Other Study ID Numbers: SSGJ-707-CRC-II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No