Metastatic Colorectal CancerPhase 2NCT06493760
A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
A Phase 2 study testing SSGJ-707, Bevacizumab and Oxaliplatin in people with Metastatic Colorectal Cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- SSGJ-707, Bevacizumab and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2024to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Signed informed consent form.
Who cannot join
- 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.
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Liu Tianshu
Shanghai, Shanghai Municipality
Liu Tianshu, PhD, 13681973996, liu.tianshu@zs-hospital.sh.cn
Liu Tianshu, PhD
About this study
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- SSGJ-707, Bevacizumab, Oxaliplatin, Capecitabine, Calcium Folinate
- Keywords
- SSGJ-707, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-707Drug
bispecific antibody
BevacizumabDrug
VEGF antibody
OxaliplatinDrug
chemotherapy
CapecitabineDrug
chemotherapy
Calcium FolinateDrug
chemotherapy
5-fluorouracilDrug
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-707(dose 1)+ XELOX | Experimental | Not described Receives: Drug: SSGJ-707; Drug: Oxaliplatin; Drug: Capecitabine |
| SSGJ-707(dose 1)+ mFOLFOX6 | Experimental | Not described Receives: Drug: SSGJ-707; Drug: Oxaliplatin; Drug: Calcium Folinate; Drug: 5-fluorouracil |
| SSGJ-707(dose 2)+ XELOX | Experimental | Not described Receives: Drug: SSGJ-707; Drug: Oxaliplatin; Drug: Capecitabine |
| SSGJ-707(dose 2)+ mFOLFOX6 | Experimental | Not described Receives: Drug: SSGJ-707; Drug: Oxaliplatin; Drug: Calcium Folinate; Drug: 5-fluorouracil |
| SSGJ-707+XELOX/mFOLFOX6 | Experimental | Not described Receives: Drug: SSGJ-707; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Calcium Folinate; Drug: 5-fluorouracil |
| Bevacizumab+XELOX/mFOLFOX6 | Active comparator | Not described Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Calcium Folinate; Drug: 5-fluorouracil |
| SSGJ-707 monotherapy | Experimental | Not described Receives: Drug: SSGJ-707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 12 months
Safety and tolerability
Safety and tolerability assessed by incidence and severity of adverse events
Measured: 12 months
Secondary outcomes (1)
PFS
The efficacy end points
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start3 Sep 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493760
- Sponsor's protocol ID
- SSGJ-707-CRC-II-01
- Status last verified
- Sep 2024
- First submitted
- 25 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT06493760
- Acronym / sponsor ID
- SSGJ-707-CRC-II-01
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- SSGJ-707, colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SSGJ-707(dose 1)+ XELOX | Experimental | Drug: SSGJ-707, Drug: Oxaliplatin, Drug: Capecitabine |
| SSGJ-707(dose 1)+ mFOLFOX6 | Experimental | Drug: SSGJ-707, Drug: Oxaliplatin, Drug: Calcium Folinate, Drug: 5-fluorouracil |
| SSGJ-707(dose 2)+ XELOX | Experimental | Drug: SSGJ-707, Drug: Oxaliplatin, Drug: Capecitabine |
| SSGJ-707(dose 2)+ mFOLFOX6 | Experimental | Drug: SSGJ-707, Drug: Oxaliplatin, Drug: Calcium Folinate, Drug: 5-fluorouracil |
| SSGJ-707+XELOX/mFOLFOX6 | Experimental | Drug: SSGJ-707, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Calcium Folinate, Drug: 5-fluorouracil |
| Bevacizumab+XELOX/mFOLFOX6 | Active comparator | Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Calcium Folinate, Drug: 5-fluorouracil |
| SSGJ-707 monotherapy | Experimental | Drug: SSGJ-707 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Signed informed consent form.
Key exclusion criteria (5 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSGJ-707bispecific antibody | Drug | SSGJ-707 monotherapy, SSGJ-707(dose 1)+ XELOX, SSGJ-707(dose 1)+ mFOLFOX6, SSGJ-707(dose 2)+ XELOX, SSGJ-707(dose 2)+ mFOLFOX6, SSGJ-707+XELOX/mFOLFOX6 |
| BevacizumabVEGF antibody | Drug | Bevacizumab+XELOX/mFOLFOX6 |
| Oxaliplatinchemotherapy | Drug | Bevacizumab+XELOX/mFOLFOX6, SSGJ-707(dose 1)+ XELOX, SSGJ-707(dose 1)+ mFOLFOX6, SSGJ-707(dose 2)+ XELOX, SSGJ-707(dose 2)+ mFOLFOX6, SSGJ-707+XELOX/mFOLFOX6 |
| Capecitabinechemotherapy | Drug | Bevacizumab+XELOX/mFOLFOX6, SSGJ-707(dose 1)+ XELOX, SSGJ-707(dose 2)+ XELOX, SSGJ-707+XELOX/mFOLFOX6 |
| Calcium Folinatechemotherapy | Drug | Bevacizumab+XELOX/mFOLFOX6, SSGJ-707(dose 1)+ mFOLFOX6, SSGJ-707(dose 2)+ mFOLFOX6, SSGJ-707+XELOX/mFOLFOX6 |
| 5-fluorouracilchemotherapy | Drug | Bevacizumab+XELOX/mFOLFOX6, SSGJ-707(dose 1)+ mFOLFOX6, SSGJ-707(dose 2)+ mFOLFOX6, SSGJ-707+XELOX/mFOLFOX6 |
Primary outcome
ORR
Time frame: 12 months
Objective response rate
Safety and tolerability
Time frame: 12 months
Safety and tolerability assessed by incidence and severity of adverse events
1 secondary outcome
PFS
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSGJ-707, Bevacizumab and Oxaliplatin in people with Metastatic Colorectal Cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.