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

NCT ID: NCT06493760

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SSGJ-707(dose 1)+ XELOX

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

bispecific antibody

Oxaliplatin

Intervention Type DRUG

chemotherapy

Capecitabine

Intervention Type DRUG

chemotherapy

SSGJ-707(dose 1)+ mFOLFOX6

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

bispecific antibody

Oxaliplatin

Intervention Type DRUG

chemotherapy

Calcium Folinate

Intervention Type DRUG

chemotherapy

5-fluorouracil

Intervention Type DRUG

chemotherapy

SSGJ-707(dose 2)+ XELOX

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

bispecific antibody

Oxaliplatin

Intervention Type DRUG

chemotherapy

Capecitabine

Intervention Type DRUG

chemotherapy

SSGJ-707(dose 2)+ mFOLFOX6

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

bispecific antibody

Oxaliplatin

Intervention Type DRUG

chemotherapy

Calcium Folinate

Intervention Type DRUG

chemotherapy

5-fluorouracil

Intervention Type DRUG

chemotherapy

SSGJ-707+XELOX/mFOLFOX6

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

bispecific antibody

Oxaliplatin

Intervention Type DRUG

chemotherapy

Capecitabine

Intervention Type DRUG

chemotherapy

Calcium Folinate

Intervention Type DRUG

chemotherapy

5-fluorouracil

Intervention Type DRUG

chemotherapy

Bevacizumab+XELOX/mFOLFOX6

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

VEGF antibody

Oxaliplatin

Intervention Type DRUG

chemotherapy

Capecitabine

Intervention Type DRUG

chemotherapy

Calcium Folinate

Intervention Type DRUG

chemotherapy

5-fluorouracil

Intervention Type DRUG

chemotherapy

SSGJ-707 monotherapy

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

bispecific antibody

Interventions

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SSGJ-707

bispecific antibody

Intervention Type DRUG

Bevacizumab

VEGF antibody

Intervention Type DRUG

Oxaliplatin

chemotherapy

Intervention Type DRUG

Capecitabine

chemotherapy

Intervention Type DRUG

Calcium Folinate

chemotherapy

Intervention Type DRUG

5-fluorouracil

chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liu Tianshu

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Liu Tianshu, PhD

Role: primary

13681973996

Liu Tianshu, PhD

Role: backup

Other Identifiers

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SSGJ-707-CRC-II-01

Identifier Type: -

Identifier Source: org_study_id

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