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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06493760
Enrollment
130
Registered
2024-07-10
Start date
2024-09-03
Completion date
2027-06-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

SSGJ-707, colorectal cancer

Brief summary

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

DRUGSSGJ-707

bispecific antibody

DRUGBevacizumab

VEGF antibody

DRUGOxaliplatin

chemotherapy

DRUGCapecitabine

chemotherapy

DRUGCalcium Folinate

chemotherapy

DRUG5-fluorouracil

chemotherapy

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ORR12 monthsObjective response rate
Safety and tolerability12 monthsSafety and tolerability assessed by incidence and severity of adverse events

Secondary

MeasureTime frameDescription
PFS24 monthsThe efficacy end points

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026