Advanced Solid Tumors PatientsPhase 1NCT06533605
Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
A Phase 1 study testing SSGJ-706 in people with Advanced Solid Tumors Patients, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd..
Trial summary
This study includes two parts, different part has different administration frequencies of SSGJ-706. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors Patients
- What is being tested?
- SSGJ-706
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to 31 Aug 2025
- Phase
- Phase 1
- 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 advanced or metastatic Solid Tumors .
- 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-706 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
No sites are listed yet.
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Initial Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
This study includes two parts, different part has different administration frequencies of SSGJ-706.
Read the detailed description
This study is a study of SSGJ-706 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of SSGJ-706. Part A is QW and part B is Q3W. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced Solid Tumors.
- Conditions
- Advanced Solid Tumors Patients
- Being tested
- SSGJ-706
- Keywords
- Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-706Drug
Bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | dose level 1 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 2 | Experimental | dose level 2 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 3 | Experimental | dose level 3 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 4 | Experimental | dose level 4 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 5 | Experimental | dose level 5 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 6 | Experimental | dose level 6 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 7 | Experimental | dose level 1 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 8 | Experimental | dose level 2 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 9 | Experimental | dose level 3 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 10 | Experimental | dose level 4 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 11 | Experimental | dose level 5 of SSGJ-706 Receives: Drug: SSGJ-706 |
| Arm 12 | Experimental | dose level 6 of SSGJ-706 Receives: Drug: SSGJ-706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Dose limiting toxicity
Measured: 12 months
MTD or MAD
maximum tolerated dose or the maximum administered dose if MTD is not reached
Measured: 12 months
Secondary outcomes (1)
The blood concentration of SSGJ-706
PK characteristics
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 posted1 Aug 2024
- Study startAug 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors PatientsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533605
- Sponsor's protocol ID
- SSGJ-706-101
- Status last verified
- Apr 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 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 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, and Initial Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06533605
- Acronym / sponsor ID
- SSGJ-706-101
- Conditions
- Advanced Solid Tumors Patients
- Keywords
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 1 Aug 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, different part has different administration frequencies of SSGJ-706.
Detailed description
This study is a study of SSGJ-706 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of SSGJ-706. Part A is QW and part B is Q3W. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced Solid Tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SSGJ-706dose level 1 of SSGJ-706 |
| Arm 2 | Experimental | Drug: SSGJ-706dose level 2 of SSGJ-706 |
| Arm 3 | Experimental | Drug: SSGJ-706dose level 3 of SSGJ-706 |
| Arm 4 | Experimental | Drug: SSGJ-706dose level 4 of SSGJ-706 |
| Arm 5 | Experimental | Drug: SSGJ-706dose level 5 of SSGJ-706 |
| Arm 6 | Experimental | Drug: SSGJ-706dose level 6 of SSGJ-706 |
| Arm 7 | Experimental | Drug: SSGJ-706dose level 1 of SSGJ-706 |
| Arm 8 | Experimental | Drug: SSGJ-706dose level 2 of SSGJ-706 |
| Arm 9 | Experimental | Drug: SSGJ-706dose level 3 of SSGJ-706 |
| Arm 10 | Experimental | Drug: SSGJ-706dose level 4 of SSGJ-706 |
| Arm 11 | Experimental | Drug: SSGJ-706dose level 5 of SSGJ-706 |
| Arm 12 | Experimental | Drug: SSGJ-706dose level 6 of SSGJ-706 |
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 advanced or metastatic Solid Tumors .
- 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-706 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-706Bispecific antibody | Drug | Arm 1, Arm 10, Arm 11, Arm 12, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8, Arm 9 |
Primary outcome
DLTs
Time frame: 12 months
Dose limiting toxicity
MTD or MAD
Time frame: 12 months
maximum tolerated dose or the maximum administered dose if MTD is not reached
1 secondary outcome
The blood concentration of SSGJ-706
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 1 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSGJ-706 in people with Advanced Solid Tumors Patients, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd..
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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Hao Chen, MD, Ph.D (15009467790, chenhao3996913@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (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 1 Aug 2024.