Sorry, you need to enable JavaScript to visit this website.
Pfizer Oncology
Loading...

The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Gastrointestinal Cancer

SSGJ-707 (PD1 x VEGF bispecific antibody)

TEST

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

Phase 2

NCT06493760

Active enrolling

Globe

Locations

China

Share to an HCP Contact Us
Study design
Participant Group/Arm

EXPERIMENTAL: SSGJ-707(dose 1)+ XELOX

Intervention/Treatment

DRUG: SSGJ-707

bispecific antibody

DRUG: Oxaliplatin

chemotherapy

DRUG: Capecitabine

chemotherapy

Participant Group/Arm

EXPERIMENTAL: SSGJ-707(dose 1)+ mFOLFOX6

Intervention/Treatment

DRUG: SSGJ-707

bispecific antibody

DRUG: Oxaliplatin

chemotherapy

DRUG: Calcium Folinate

chemotherapy

DRUG: 5-fluorouracil

chemotherapy

Participant Group/Arm

EXPERIMENTAL: SSGJ-707(dose 2)+ XELOX

Intervention/Treatment

DRUG: SSGJ-707

bispecific antibody

DRUG: Oxaliplatin

chemotherapy

DRUG: Capecitabine

chemotherapy

Participant Group/Arm

EXPERIMENTAL: SSGJ-707(dose 2)+ mFOLFOX6

Intervention/Treatment

DRUG: SSGJ-707

bispecific antibody

DRUG: Oxaliplatin

chemotherapy

DRUG: Calcium Folinate

chemotherapy

DRUG: 5-fluorouracil

chemotherapy

Participant Group/Arm

EXPERIMENTAL: SSGJ-707+XELOX/mFOLFOX6

Intervention/Treatment

DRUG: SSGJ-707

bispecific antibody

DRUG: Oxaliplatin

chemotherapy

DRUG: Capecitabine

chemotherapy

DRUG: Calcium Folinate

chemotherapy

DRUG: 5-fluorouracil

chemotherapy

Participant Group/Arm

ACTIVE_COMPARATOR: Bevacizumab+XELOX/mFOLFOX6

Intervention/Treatment

DRUG: Bevacizumab

VEGF antibody

DRUG: Oxaliplatin

chemotherapy

DRUG: Capecitabine

chemotherapy

DRUG: Calcium Folinate

chemotherapy

DRUG: 5-fluorouracil

chemotherapy

Participant Group/Arm

EXPERIMENTAL: SSGJ-707 monotherapy

Intervention/Treatment

DRUG: SSGJ-707

bispecific antibody

Study design table for Clinical Trial
Key eligibility criteria
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.
Key dates
Study start date
  • September 2024
Estimated Study Completion Date
  • June 2027
Key endpoints
Primary Outcome Measures
Outcome Measure

ORR

Measure Description

Objective response rate

Time Frame

12 months

Outcome Measure

Safety and tolerability

Measure Description

Safety and tolerability assessed by incidence and severity of adverse events

Time Frame

12 months

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

PFS

Measure Description

The efficacy end points

Time Frame

24 months

Secondary Outcome Measures table for Clinical Trial
Number of participants

130

Collaborators and investigators

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

Collaborator: None

This information is current as of September 19th 2024.

Contact Us
Close

For more information, call or email the Pfizer Clinical Trial Contact Center:

1-800-887-7002 Email us

When calling, please reference this study number:

More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT06493760