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

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and/or females over age 18

Histologically and/or cytologically documented metastatic colorectal cancer confirmed .

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Expected survival >=12 weeks.

Disqualifiers

Known uncontrolled or symptomatic central nervous system metastatic disease.

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).

Inadequate organ or bone marrow function.

Pregnant or breast-feeding woman.

Trial design

Design model

Single group

Treatments tested in this trial

  • SSGJ-707

    Drug

    bispecific antibody

  • Bevacizumab

    Drug

    VEGF antibody

  • Oxaliplatin

    Drug

    chemotherapy

  • Capecitabine

    Drug

    chemotherapy

  • Calcium Folinate

    Drug

    chemotherapy

  • 5-fluorouracil

    Drug

    chemotherapy

Treatment groups

130 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: SSGJ-707(dose 1)+ XELOXExperimental treatment 3 interventions
Group B: SSGJ-707(dose 1)+ mFOLFOX6Experimental treatment 4 interventions
Group C: SSGJ-707(dose 2)+ XELOXExperimental treatment 3 interventions
Group D: SSGJ-707(dose 2)+ mFOLFOX6Experimental treatment 4 interventions
Group E: SSGJ-707+XELOX/mFOLFOX6Experimental treatment 5 interventions
Group F: Bevacizumab+XELOX/mFOLFOX6Active comparator 5 interventions
Group G: SSGJ-707 monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate

Time frame
12 months
2

Safety and tolerability

Safety and tolerability assessed by incidence and severity of adverse events

Time frame
12 months

Secondary outcomes

1

PFS

The efficacy end points

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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