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

Sunshine Guojian Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: 5-fluorouracil; Drug: Bevacizumab; Drug: Capecitabine; Drug: SSGJ-707; Drug: Oxaliplatin; Drug: Calcium Folinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06493760

SSGJ-707-CRC-II-01

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 7 patient groups

SSGJ-707(dose 1)+ XELOX

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: SSGJ-707

Drug: Capecitabine

SSGJ-707(dose 1)+ mFOLFOX6

Experimental group

Treatment:

Drug: Calcium Folinate

Drug: Oxaliplatin

Drug: SSGJ-707

Drug: 5-fluorouracil

SSGJ-707(dose 2)+ XELOX

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: SSGJ-707

Drug: Capecitabine

SSGJ-707(dose 2)+ mFOLFOX6

Experimental group

Treatment:

Drug: Calcium Folinate

Drug: Oxaliplatin

Drug: SSGJ-707

Drug: 5-fluorouracil

SSGJ-707+XELOX/mFOLFOX6

Experimental group

Treatment:

Drug: Calcium Folinate

Drug: Oxaliplatin

Drug: SSGJ-707

Drug: Capecitabine

Drug: 5-fluorouracil

Bevacizumab+XELOX/mFOLFOX6

Active Comparator group

Treatment:

Drug: Calcium Folinate

Drug: Oxaliplatin

Drug: Capecitabine

Drug: 5-fluorouracil

Drug: Bevacizumab

SSGJ-707 monotherapy

Experimental group

Treatment:

Drug: SSGJ-707