Receptor, ErbB-2Phase 1NCT05145179
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors
A Phase 1 study testing SSGJ-705 in people with Receptor, ErbB-2, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd..
Trial summary
The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered，the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Receptor, ErbB-2
- What is being tested?
- SSGJ-705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 year, male or female.
- Life expectancy ≥12 weeks (according to Investigator's judgement).
- Patients with histologically or cytologically confirmed locally advanced or metastatic non resectable HER2-expressing Solid Tumors
- Patients who have at least one measurable lesion (radiation-naïve) according to RECIST v1.1
- ECOG performance status 0-1
- Adequate organ and bone marrow function evaluated by laboratory tests
- Male patients who are surgically sterilized or who agree to use highly effective contraceptive measures during the study and for at least 6 months after administration of the last study drug dose
- Willing to provide written informed consent and willing and able to comply with all study procedures.
Who cannot join
- Receive chemotherapy, targeted therapy, or other antitumor therapy within 3 weeks prior to initial dosing
- Patients whose toxicity due to previous anticancer therapy has not been reduced to NCI CTCAE Grade 1 or lower, or any greater than NCI CTCAE 1 AE exists within 2 weeks before enrollment, not including hair loss and fatigue
- Patients requiring systemic systemic therapy with systemic hormones or other immunosuppressive agents within 4 weeks prior to initial administration and during the study period
- Previous cumulative doses of adriamycin > 720 mg/m2, adriamycin >360 mg/m2 or other cumulative doses of adriamycin were converted to equal doses of adriamycin >360 mg/m2
- Patients who underwent major surgery within 4 weeks of initial dosing and have not fully recovered or who plan to undergo major surgery during the trial
- In addition to palliative radiotherapy, other anticancer treatments not specified in the protocol are planned for the duration of the trial
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- Always received total pelvic radiotherapy
- Had an active or prior autoimmune or inflammatory disease within the last 3 years prior to study treatment
- Severe disease of cardiovascular and cerebrovascular diseases
- History of active tuberculosis
- A history of (non-infectious) pneumonia/interstitial pneumonia or a history of present pneumonia/interstitial pneumonia requiring steroid treatment
- Severe dyspnea or the need for supplemental oxygen therapy at rest due to complications of advanced malignancy; Newly diagnosed or symptomatic central nervous system (CNS) metastasis, spinal cord compression, or cancerous meningitis
- Persons with a history of primary immunodeficiency disease, including but not limited to HIV-positive serum
- Hepatitis B virus (HBV) and hepatitis C virus (HCV) positive subjects
- Women/men who are pregnant or breast-feeding or planning to give birth
- A history of mental or substance abuse that may affect study compliance
- Allergy to other antibody drugs or to any excipients in the study drug
- Who received live vaccine within 30 days prior to initial administration (within 72 hours for COVID-19 vaccine), or who plan to receive any live vaccine during the study
- Previous organ and allogeneic stem cell transplants (except transplants that do not require immunosuppressive therapy, such as corneal and hair transplants)
- Participated in any medical device or drug clinical study within 1 month prior to screening
- The inestigators considered that this would significantly increase the risk of administration of the investigational drug, or that it would affect efficacy evaluation or other conditions requiring exclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I, Multicenter, Open-Label, First-in-Human Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors
The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered，the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and immunogenicity evaluation.
- Conditions
- Receptor, ErbB-2
- Being tested
- SSGJ-705
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-705Drug
0.1, 1, 3, 6, 10, 15 or 20mg/kg, IV, Day 1, 8, 15 of each treatment cycle, up to disease progression or intolerable toxicity, death, early withdrawal from the study or loss to follow-up, withdrawal of consent, or the end of the treatment period, whichever occurs first. Every 4 weeks a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| HER2-expressing Solid Tumors | Experimental | SSGJ-705 Administered via intravenous (IV) infusion Receives: Drug: SSGJ-705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-limiting toxicity（part 1）
Measured: At the end of Cycle 1 (each cycle is 28 days)
MTD
maximum tolerated dose（part 1）
Measured: up to 1 years
RP2D
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators recommended Phase II dose（part 1）
Measured: up to 1 years
ORR
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment（part 2）
Measured: up to 1 years
Secondary outcomes (6)
Adverse events
the safety of SSGJ-705 in patients with advanced or metastatic HER2-expressing solid tumors who have failed standard treatment
Measured: up to 1 years
Maximum Plasma Concentration (Cmax)
To evaluate the Cmax of single and multiple doses of SSGJ-705 in patients with advanced or metastatic HER2 expressing solid tumors who have failed standard treatments
Measured: up to 1 years
Area Under the Curve (AUC)
To evaluate the AUC of single and multiple doses of SSGJ-705 in patients with advanced or metastatic HER2 expressing solid tumors who have failed standard treatments
Measured: up to 1 years
incidence of anti-609A antibodies
incidence of anti-609A antibodies
Measured: up to 1 years
Median Progression-free Survival (PFS)
The Kaplan-Meier method will be used to estimate median PFS.
Measured: up to 1 years
Overall Survival (OS)
The Kaplan-Meier method will be used to estimate median OS.
Measured: up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Receptor, ErbB-2Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zefei Jiang, PhD, Principal investigator, The Fifth Medical Center of the People's Liberation ArmyYing Cheng, PhD, Principal investigator, Jilin Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145179
- Sponsor's protocol ID
- SSGJ-705-ST-I-01
- Status last verified
- Jul 2021
- First submitted
- 25 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-Label, First-in-Human Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors
- ClinicalTrials.gov ID
- NCT05145179
- Acronym / sponsor ID
- SSGJ-705-ST-I-01
- Conditions
- Receptor, ErbB-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 6 Dec 2021 (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.
The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered，the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and immunogenicity evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-expressing Solid Tumors | Experimental | Drug: SSGJ-705SSGJ-705 Administered via intravenous (IV) infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 year, male or female.
- Life expectancy ≥12 weeks (according to Investigator's judgement).
- Patients with histologically or cytologically confirmed locally advanced or metastatic non resectable HER2-expressing Solid Tumors
- Patients who have at least one measurable lesion (radiation-naïve) according to RECIST v1.1
- ECOG performance status 0-1
Key exclusion criteria (21 listed)
- Receive chemotherapy, targeted therapy, or other antitumor therapy within 3 weeks prior to initial dosing
- Patients whose toxicity due to previous anticancer therapy has not been reduced to NCI CTCAE Grade 1 or lower, or any greater than NCI CTCAE 1 AE exists within 2 weeks before enrollment, not including hair loss and fatigue
- Patients requiring systemic systemic therapy with systemic hormones or other immunosuppressive agents within 4 weeks prior to initial administration and during the study period
- Previous cumulative doses of adriamycin > 720 mg/m2, adriamycin >360 mg/m2 or other cumulative doses of adriamycin were converted to equal doses of adriamycin >360 mg/m2
- Patients who underwent major surgery within 4 weeks of initial dosing and have not fully recovered or who plan to undergo major surgery during the 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-7050.1, 1, 3, 6, 10, 15 or 20mg/kg, IV, Day 1, 8, 15 of each treatment cycle, up to disease progression or intolerable toxicity, death, early withdrawal from the study or loss to follow-up, withdrawal of consent, or the end of the treatment period, whichever occurs first. Every 4 weeks a treatment cycle. | Drug | HER2-expressing Solid Tumors |
Primary outcome
DLT
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Dose-limiting toxicity（part 1）
MTD
Time frame: up to 1 years
maximum tolerated dose（part 1）
RP2D
Time frame: up to 1 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators recommended Phase II dose（part 1）
ORR
Time frame: up to 1 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment（part 2）
6 secondary outcomes
Adverse events
Time frame: up to 1 years
Maximum Plasma Concentration (Cmax)
Time frame: up to 1 years
Area Under the Curve (AUC)
Time frame: up to 1 years
incidence of anti-609A antibodies
Time frame: up to 1 years
Median Progression-free Survival (PFS)
Time frame: up to 1 years
Overall Survival (OS)
Time frame: up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- 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.
Zefei Jiang, PhD principal investigator
The Fifth Medical Center of the People's Liberation Army
Ying Cheng, PhD principal investigator
Jilin Provincial Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSGJ-705 in people with Receptor, ErbB-2, 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 8 inclusion and 21 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 6 Dec 2021. 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 Lili Zheng, PMD (18511272561, zhenglili@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 4 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 6 Dec 2021.