NSCLCPhase 2NCT06361927
A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients
A Phase 2 study testing SSGJ-707 in people with NSCLC, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- SSGJ-707
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=3 months.
- 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.
China1 site, 1 recruiting
- Recruiting
The Hunan Cancer Hospital
Changsha, Hunan
Lin Wu, MD,Ph.D, 0731-89762302, wulin-calf@vip.163.com
About this study
This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC.
Read the detailed description
This study is a study of SSGJ-707 monotherapy in First-line PD-L1 Positive advanced NSCLC Patients. This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. Each cohort will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.
- Conditions
- NSCLC
- Being tested
- SSGJ-707
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-707Drug
bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| cohort A：dose level 1 of SSGJ-707 | Experimental | Not described Receives: Drug: SSGJ-707 |
| cohort A：dose level 2 of SSGJ-707 | Experimental | Not described Receives: Drug: SSGJ-707 |
| cohort A：dose level 3 of SSGJ-707 | Experimental | Not described Receives: Drug: SSGJ-707 |
| cohort B：dose level 1 of SSGJ-707 | Experimental | Not described Receives: Drug: SSGJ-707 |
| cohort B：dose level 2 of SSGJ-707 | Experimental | cohort B Receives: Drug: SSGJ-707 |
| cohort B：dose level 3 of SSGJ-707 | 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
Secondary outcomes (1)
Safety and tolerability
Safety and tolerability assessed by incidence and severity of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start15 May 2024
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Wu, MD, Ph.D, Principal investigator, The Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361927
- Sponsor's protocol ID
- SSGJ-707-NSCLC-II-01
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 16 May 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients
- ClinicalTrials.gov ID
- NCT06361927
- Acronym / sponsor ID
- SSGJ-707-NSCLC-II-01
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 12 Apr 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 cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC.
Detailed description
This study is a study of SSGJ-707 monotherapy in First-line PD-L1 Positive advanced NSCLC Patients. This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. Each cohort will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| cohort A：dose level 1 of SSGJ-707 | Experimental | Drug: SSGJ-707 |
| cohort A：dose level 2 of SSGJ-707 | Experimental | Drug: SSGJ-707 |
| cohort A：dose level 3 of SSGJ-707 | Experimental | Drug: SSGJ-707 |
| cohort B：dose level 1 of SSGJ-707 | Experimental | Drug: SSGJ-707 |
| cohort B：dose level 2 of SSGJ-707 | Experimental | Drug: SSGJ-707cohort B |
| cohort B：dose level 3 of SSGJ-707 | 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 local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=3 months.
- 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 | cohort A：dose level 1 of SSGJ-707, cohort A：dose level 2 of SSGJ-707, cohort A：dose level 3 of SSGJ-707, cohort B：dose level 1 of SSGJ-707, cohort B：dose level 2 of SSGJ-707, cohort B：dose level 3 of SSGJ-707 |
Primary outcome
ORR
Time frame: 12 months
Objective response rate
1 secondary outcome
Safety and tolerability
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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. This study is not recruiting at the moment.
Lin Wu, MD, Ph.D principal investigator
The Hunan Cancer Hospital
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 in people with NSCLC, 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: status not confirmed, as of the sponsor's last update on 16 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Wu, MD, Ph.D (0731-89762302, wulin-calf@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 12 months). 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 16 May 2024.