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

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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