Alveolar Soft Part SarcomaPhase 2NCT03623581
Clinical Trial in Chinese Patients of Elapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma(GB226)
A Phase 2 study testing GB226 in people with Alveolar Soft Part Sarcoma, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
This study is a single-arm, phase 2 trial of Geptanolimab in patients with initially unresectable, recurrent or metastatic ASPS. The study aims to study the activity of Geptanolimab assessed per RECIST 1.1 and iRECIST criteria, and safety profile. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alveolar Soft Part Sarcoma
- What is being tested?
- GB226
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2018to 30 Dec 2022
- 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
- The subjects can be enrolled only all the following criteria are met:
- Sign the informed consent form;
- Aged 18~75 years old, males or females;
- ECOG score of 0-1;
- The expected survival is 3 months or longer;
- Histologically or cytologically confirmed relapsed or metastatic or unresectable alveolar soft part sarcoma (ASPS);
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- There is at least one measurable lesion, which is defined as lesion accurately measured in one dimension (RECIST1.1: the longest diameter of non-lymph node lesions≥10mm, the shortest diameter of lymph node lesions ≥15mm);
- The previous treatment is completed ≥4 weeks or ≥5 half-lives of the previous therapeutic agents (whichever is shorter) before administration (at least 1 week interval between previous treatment and study enrollment); washout with nitrosoureas, mitomycin C, RANKL inhibitor for at least 6 weeks; previous radiotherapy must be performed at least 4 weeks ago; the previous monoclonal antibody treatment must be performed at least 6 weeks ago;
- If the patients received more than 350mg/m2 cumulative dose of adriamycin, echocardiography should be performed and left ventricular ejection fraction (LVEF) ≥50%;
- Absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, hemoglobin (Hb) ≥80g/L;
- Total bilirubin ≤1.5xULN (≤3xULN is allowed for known Gilbert disease), AST/ALT≤3xULN (AST and/or ALT≤5xULN is allowed for patients with hepatic metastasis), ALP≤2.5xULN (≤5xULN is allowed for patients with hepatic metastasis or bone metastasis);
- The creatinine clearance ≥ 50mL/min/1.73m2 (calculated based on Cockcroft-Gault formula) or Cr≤1.5xULN;
- Female subjects who are confirmed not pregnant within 72 hours before administration; female and male patients of child-bearing potential should agree to adopt adequate contraceptive methods before enrollment, during study period and 6 months after the last dose;
- Lactating women should agree to stop breastfeeding during the study period;
- Agree to provide archived tumor tissue specimens or fresh tissue specimens;
Who cannot join
- The subjects cannot be enrolled should any of or several conditions occur:
- Subjects who received anti-PD-1 or anti-PD-L1 monoclonal antibody or targeted drugs of relevant pathways;
- Subjects who are known to be allergic to PD-1 monoclonal antibody or any of its excipients, or subjects who are known to have medical history of allergic diseases or serious allergic constitution;
- Subjects who received CTLA-4 antibody;
- Subjects who have other malignant tumor diseases other than tumor treated in this study, excluding cured malignant tumors which did not relapse within 3 years before enrollment, completely resected basal cell and squamous cell skin cancer, any type of in situ carcinoma which is completely resected;
- Active central nervous system (CNS) metastasis (regardless of whether any treatment is received), including symptomatic brain metastasis or meningeal metastasis or spinal cord compression etc.; excluding asymptomatic brain metastasis (no progression within at least 4 weeks after radiotherapy and/or no neurological symptom or sign after surgical resection, treatment with dexamethasone or mannitol is not necessary);
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- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- The toxicity of previous treatment still > grade 1 (CTCAEV4.03 criteria), excluding alopecia and neurotoxicity;
- Subjects who have history of psychiatric disorders;
- Subjects who have medical history of drug addiction or drug abuse;
- Subjects with medical history of idiopathic pulmonary fibrosis or idiopathic pneumonitis, or patients who previously received radiotherapy for large size of lungs;
- Patients with complications requiring treatment with immunosuppressive drugs or systemic or local corticosteroids at the immunosuppressive doses (prednisone > 10mg/day or equivalent dose of similar agents);
- Medical history of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory gastrointestinal disorders, Hashimoto's thyroiditis etc. The following should be excluded: type I diabetes mellitus, hypothyroidism which can be controlled by hormone replacement therapies only, skin diseases requiring no systemic treatment (e.g., vitiligo, psoriasis), controlled celiac disease, or diseases which may not occur without stimulating factors;
- Subjects who previously or currently have active tuberculosis;
- Subjects with active infection requiring systemic treatment;
- Uncontrolled hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) or pulmonary arterial hypertension or unstable angina pectoris; previous presence of myocardial infarction or received bypass grafting or stent surgery within 6 months before administration; medical history of chronic heart failure NYHA (New York Heart Association) class 3-4; Clinically significant valvular heart diseases; subjects with serious arrhythmia requiring treatment (excluding atrial fibrillation, paroxysmal supraventricular tachycardia), including QTc interval ≥450ms for males and ≥470ms for females (calculated based on Fridericia formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months before administration;
- Subjects with complicated serious internal diseases, including but not limited to, uncontrolled diabetes mellitus, active gastrointestinal ulcer, active bleeding etc.;
- Positive Anti-HIV, TP-Ab, HCV-Ab; positive HBV-Ag and the copies of HBV DNA are higher than the upper limit of normal of the test units;
- Abnormal thyroid function test (TSH, FT3, FT4);
- Expected major surgery within 28 days before administration or during treatment period;
- It is expected that live vaccines or attenuated vaccines are given 4 weeks before administration, during treatment period or within 5 months after the last dose;
- Subjects who participated in another clinical trial and were treated with investigational products within 30 days before screening;
- Patients who require RANKL inhibitor (e.g., denosumab);
- Patients who have insufficient communication, understanding and cooperation; or patients who have poor compliance and cannot guarantee to strictly follow the study protocol;
- Subjects who are considered unsuitable for participating in this clinical study for any other reasons at the discretion of the investigator;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, Doctor
Yuankai Shi, Doctor
About this study
Official title: An Open-label, Single-arm, Phase II Clinical Study of Anti-PD-1 Antibody GB226 in Treatment of Relapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma (ASPS)
This study is a single-arm, phase 2 trial of Geptanolimab in patients with initially unresectable, recurrent or metastatic ASPS. The study aims to study the activity of Geptanolimab assessed per RECIST 1.1 and iRECIST criteria, and safety profile.
Read the detailed description
Patients received Geptanolimab 3mg/kg via intraveneous infusion every 2 weeks until disease progression, death, unacceptable toxicity, withdrawal of consent or end the the study (i.e. a maximum treatment duration of one years of the last subject, termination of treatment, consent withdrawal, lost to follow-up or death, whichever occurs first).
During the treatment period, subjects were evaluated for safety (once every 2 weeks) and efficacy (once every 6 weeks)，If clinical symptoms suggestive of PD occur, an external visit should be arranged to complete the imaging evaluation and confirmation.
Geptanolimab treatment was permitted to continue beyond the first RECIST-defined progressive disease (PD), if clinical benefit was noted and the toxicity was acceptable. No dose modification was allowed, but dose discontinuation was permitted for up to six weeks for adverse events.
Safety was monitored until 30 days and/or 90 days (without initiation of another anticancer treatment) after the last dose of the study drug, for all patients received at least one dose of treatment.
At the end of the treatment, for the subjects who have not yet developed PD and have not started the subsequent anti-tumor treatment, the efficacy evaluation will continue every 6 weeks (± 7 days) in the first 3 months, and every 12 weeks thereafter, until the end of the study or withdrawal of informed consent or occurrence of PD, initiation of a new anti-tumor treatment, death or lost to follow-up.
All subjects who had received GB226 treatment at least once were required to have survival follow-up visits, which were planned every 3 months (± 14 days) after the safety follow-up / disease progression follow-up visit.
The end of the study was defined as the death, loss of visit, withdrawal of informed consent and completion of the final study visit of the last subject, and the end of treatment of the last subject for one year or the early end of the study, whichever occurs first.
- Conditions
- Alveolar Soft Part Sarcoma
- Being tested
- GB226
- Keywords
- ASPS
- Medical subject headings
- Sarcoma, Alveolar Soft Part
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB226Biological
Also called Recombinant humanized anti-PD-1 monoclonal antibody injection, Geptanolimab
3mg/kg treat every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| GB226 3mg/kg every 2 weeks | Experimental | Geptanolimab Injection, 3mg/kg every 2 weeks Receives: Biological: GB226 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate, ORR
To evaluate the efficacy of GB226 as defined by objective response rate in patients with ASPS.
Measured: up to 52 weeks
Secondary outcomes (12)
Progression-free survival, PFS
To evaluate the efficacy of GB226 as defined by progression-free survival in patients with ASPS.
Measured: up to 52 weeks
Duration of response, DOR
To evaluate the duration of response (DOR) of GB226 in patients with ASPS.
Measured: up to 52 weeks
Disease Control Rate，DCR
To evaluate the disease Control Rate (DCR) of GB226 in patients with ASPS.
Measured: up to 52 weeks
Overall survival, OS
To evaluate the duration from the first administration to death because of any reason in patients with ASPS.
Measured: up to 52 weeks
Incidence and severity of adverse events
Incidence and severity of adverse events
Measured: up to 52 weeks
Incidence and severity of immune-related adverse events
Incidence and severity of immune-related adverse events
Measured: up to 52 weeks
Incidence and severity of serious adverse events
Incidence and severity of serious adverse events
Measured: up to 52 weeks
iORR
iORR
Measured: up to 52 weeks
iDCR
iDCR
Measured: up to 52 weeks
iPFS
iPFS
Measured: up to 52 weeks
iDOR
iDOR
Measured: up to 52 weeks
The concentration of Antidrug antibody
To evaluate the immunogenicity in patients with ASPS.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start6 Sep 2018
- Primary completionAug 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Soft Part SarcomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Doctor, Principal investigator, Study Principal Investigator Cancer Hospital Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623581
- Sponsor's protocol ID
- Gxplore-005
- Status last verified
- Mar 2021
- First submitted
- 26 Jul 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Phase II Clinical Study of Anti-PD-1 Antibody GB226 in Treatment of Relapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma (ASPS)
- ClinicalTrials.gov ID
- NCT03623581
- Acronym / sponsor ID
- Gxplore-005
- Conditions
- Alveolar Soft Part Sarcoma
- Keywords
- ASPS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 9 Aug 2018 (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 is a single-arm, phase 2 trial of Geptanolimab in patients with initially unresectable, recurrent or metastatic ASPS. The study aims to study the activity of Geptanolimab assessed per RECIST 1.1 and iRECIST criteria, and safety profile.
Detailed description
Patients received Geptanolimab 3mg/kg via intraveneous infusion every 2 weeks until disease progression, death, unacceptable toxicity, withdrawal of consent or end the the study (i.e. a maximum treatment duration of one years of the last subject, termination of treatment, consent withdrawal, lost to follow-up or death, whichever occurs first).
During the treatment period, subjects were evaluated for safety (once every 2 weeks) and efficacy (once every 6 weeks)，If clinical symptoms suggestive of PD occur, an external visit should be arranged to complete the imaging evaluation and confirmation.
Geptanolimab treatment was permitted to continue beyond the first RECIST-defined progressive disease (PD), if clinical benefit was noted and the toxicity was acceptable. No dose modification was allowed, but dose discontinuation was permitted for up to six weeks for adverse events.
Safety was monitored until 30 days and/or 90 days (without initiation of another anticancer treatment) after the last dose of the study drug, for all patients received at least one dose of treatment.
At the end of the treatment, for the subjects who have not yet developed PD and have not started the subsequent anti-tumor treatment, the efficacy evaluation will continue every 6 weeks (± 7 days) in the first 3 months, and every 12 weeks thereafter, until the end of the study or withdrawal of informed consent or occurrence of PD, initiation of a new anti-tumor treatment, death or lost to follow-up.
All subjects who had received GB226 treatment at least once were required to have survival follow-up visits, which were planned every 3 months (± 14 days) after the safety follow-up / disease progression follow-up visit.
The end of the study was defined as the death, loss of visit, withdrawal of informed consent and completion of the final study visit of the last subject, and the end of treatment of the last subject for one year or the early end of the study, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB226 3mg/kg every 2 weeks | Experimental | Biological: GB226Geptanolimab Injection, 3mg/kg every 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sign the informed consent form;
- Aged 18~75 years old, males or females;
- ECOG score of 0-1;
- The expected survival is 3 months or longer;
- Histologically or cytologically confirmed relapsed or metastatic or unresectable alveolar soft part sarcoma (ASPS);
Key exclusion criteria (25 listed)
- Subjects who received anti-PD-1 or anti-PD-L1 monoclonal antibody or targeted drugs of relevant pathways;
- Subjects who are known to be allergic to PD-1 monoclonal antibody or any of its excipients, or subjects who are known to have medical history of allergic diseases or serious allergic constitution;
- Subjects who received CTLA-4 antibody;
- Subjects who have other malignant tumor diseases other than tumor treated in this study, excluding cured malignant tumors which did not relapse within 3 years before enrollment, completely resected basal cell and squamous cell skin cancer, any type of in situ carcinoma which is completely resected;
- Active central nervous system (CNS) metastasis (regardless of whether any treatment is received), including symptomatic brain metastasis or meningeal metastasis or spinal cord compression etc.; excluding asymptomatic brain metastasis (no progression within at least 4 weeks after radiotherapy and/or no neurological symptom or sign after surgical resection, treatment with dexamethasone or mannitol is not necessary);
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 |
|---|---|---|
| GB226Also: Recombinant humanized anti-PD-1 monoclonal antibody injection, Geptanolimab3mg/kg treat every 2 weeks | Biological | GB226 3mg/kg every 2 weeks |
Primary outcome
Objective Response Rate, ORR
Time frame: up to 52 weeks
To evaluate the efficacy of GB226 as defined by objective response rate in patients with ASPS.
12 secondary outcomes
Progression-free survival, PFS
Time frame: up to 52 weeks
Duration of response, DOR
Time frame: up to 52 weeks
Disease Control Rate，DCR
Time frame: up to 52 weeks
Overall survival, OS
Time frame: up to 52 weeks
Incidence and severity of adverse events
Time frame: up to 52 weeks
Incidence and severity of immune-related adverse events
Time frame: up to 52 weeks
Incidence and severity of serious adverse events
Time frame: up to 52 weeks
iORR
Time frame: up to 52 weeks
iDCR
Time frame: up to 52 weeks
iPFS
Time frame: up to 52 weeks
iDOR
Time frame: up to 52 weeks
The concentration of Antidrug antibody
Time frame: up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
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Active, not recruitingPhase 2
Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma
Metastatic Alveolar Soft Part Sarcoma, Unresectable Alveolar Soft Part Sarcoma
Active, not recruitingPhase 2
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
Adrenal Cortical Carcinoma, Alveolar Soft Part Sarcoma
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.
Yuankai Shi, Doctor principal investigator
Study Principal Investigator Cancer Hospital Chinese Academy of Medical Sciences
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 GB226 in people with Alveolar Soft Part Sarcoma, run by Genor Biopharma 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 15 inclusion and 25 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 3 Mar 2021. 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 Shawn Yu, Master (86-010-65260820, shawn.yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate, ORR (time frame: up to 52 weeks). 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 3 Mar 2021.