Malignant Pleural EffusionPhase 1NCT04123886
A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion
A Phase 1 study testing SCB-313 in people with Malignant Pleural Effusion, run by Sichuan Clover Biopharmaceuticals, Inc. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of single dose of SCB-313 by intrapleural injection.To evaluate the safety and tolerability of repeated dose of SCB-313 by intrapleural injection once a day for 3 days, and to determine the maximum tolerated dose (MTD) of SCB-313. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- SCB-313
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2020to 31 Mar 2022
- 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
- Histologically or cytologically confirmed cancer of any primary tumor type.
- Malignant pleural effusion requiring drainage that is histologically or cytologically confirmed;
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2. Patients with an ECOG performance status of 3 may be included if the Investigator determines that removal of pleural fluid would improve their performance status to 2 or better.
- Life expectancy of at least 8 weeks.
- Age ≥18 years and ≤ 75 years;.
- Body weight ≥45 kg and body mass index ≥17 kg/m2.
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- Adequate hematologic function, defined as:
- Platelet count ≥80,000/μL;
- Prothrombin time and activated partial thromboplastin time ≤1.5 times the upper limit of normal (ULN);
- Absolute neutrophil count ≥1,500 μL;
- Hemoglobin ≥8 g/dL (transfusion and erythropoietic agents are allowed). In case there is existence of active bleeding or other persistent condition of either increased destruction or impaired production of erythrocytes, which may require repeated transfusion or erythropoietic treatment, the eligibility must be discussed with the Sponsor on a case by-case basis prior to randomization.
- Ablumin≥35g/L
- Adequate renal function, defined as serum creatinine ≤2.0 times ULN and creatinine clearance >50 mL/minute.
- Adequate liver function, defined as:
- Aspartate aminotransferase and alanine aminotransferase ≤2.0 times ULN for patients without liver metastases, or ≤5 times ULN in the presence of liver metastases;
- Bilirubin ≤2.0 times ULN, unless patient has known Gilberts syndrome.
- Female patients of childbearing potential (excluding women who have undergone surgical sterilization or are menopausal, defined as no menstrual periods for 1 year or more without any other medical reasons) are eligible if they have negative serum pregnancy test result 7 days before the first dose of SCB-313 and are willing to use an effective method of birth control/contraception to prevent pregnancy until 6 months after discontinuation of SCB-313.
- Both men and women of reproductive potential must agree to use effective contraception during the study and for 6 months after discontinuation of SCB 313.
- Note: Contraceptive methods that are considered highly effective areas follows: total abstinence, intrauterine device, double barrier method (such as condom plus diaphragm with spermicide), contraceptive implant, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release), or vasectomized partner with confirmed azoospermia.
- Willing to attend follow-up visits according to study protocol.
Who cannot join
- Significantly loculated pleural effusions not amenable to drainage or patient is unlikely to benefit from intrapleural therapy.
- Any anti-tumor drug other than the systemic anti-tumor therapy that the subject has stably used and any treatment that may have an effect on the control of pleural effusions. Prior therapy with monoclonal antibody should be stopped per Investigators judgement making sure delayed side effects will not interfere with the DLT evaluation period after SCB-313 therapy.
- Acute or chronic infection (such as tuberculosis) requiring antiviral or intravenous antibiotics within 2 weeks prior to enrollment.
- Clinical unstable or uncontrolled concomitant hematologic, cardiovascular, pulmonary, hepatic, renal, pancreatic, or endocrine diseases.
- History of gross hemoptysis (>2.5 mL) within 3 months prior to enrollment.
- Residual adverse events (AEs) > Grade 2 from previous treatment.
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- Evidence or suspicion of relevant psychiatric impairment, including alcohol or recreational drug abuse.
- Myocardial infarction within 6 months prior to treatment and/or prior diagnoses of congestive heart failure (New York Heart Association Class III or IV), unstable angina, unstable cardiac arrhythmia requiring medication, and/or long QT syndrome or QT/QTc interval >450 msec at Baseline.
- Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg confirmed upon repeated measures (note: no more than 3 repeated measures allowed).
- Major surgery (open procedures) within 4 weeks prior to enrollment.
- Patient with ileus within 30 days prior to Screening.
- Positive serology test for human immunodeficiency virus,Syphilis, Hepatitis B virus(HBV) and/or Hepatitis C virus(HCV).
- Live vaccine within 2 weeks prior to enrollment.
- Scheduled participation in another clinical study involving an investigational product or device during the DLT observation period of this study.
- Previous treatment with a TRAIL-based therapy or death receptor 4/5 agonist therapy.
- Known or suspected hypersensitivity to any component of SCB-313.
- Any further condition which, in the opinion of the Investigator, may result in undue risk of the patient by participating in the present study.
- Untreated or uncontrolled central nervous system metastatic disease, leptomeningeal disease, or cord compression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of SCB-313, Recombinant Human Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand-Trimer Fusion Protein, for the Treatment of Malignant Pleural Effusion
To evaluate the safety and tolerability of single dose of SCB-313 by intrapleural injection.To evaluate the safety and tolerability of repeated dose of SCB-313 by intrapleural injection once a day for 3 days, and to determine the maximum tolerated dose (MTD) of SCB-313.
- Conditions
- Malignant Pleural Effusion
- Being tested
- SCB-313
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCB-313Drug
SCB-313 Intrapleural injection, once daily. Single dose on Day 1 in Cycle 0 followed by 7-day safety assessment, then dose on Day 1,2,3 in Cycle 1 followed by 21-day observation .
| Study group | Role | What they receive |
|---|---|---|
| SCB-313 | Experimental | Not described Receives: Drug: SCB-313 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose Limiting Toxicity
Measured: 28 days after first dosing
Secondary outcomes (2)
AEs
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 28 days after first dosing
Immunogenicity
Occurrence of binding and neutralizing anti-SCB-313 antibodies
Measured: up to 28 days after first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start8 Jan 2020
- Primary completion30 Sep 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Clover Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123886
- Sponsor's protocol ID
- CLO-SCB-313-CHN-002
- Status last verified
- May 2022
- First submitted
- 9 Oct 2019
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of SCB-313, Recombinant Human Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand-Trimer Fusion Protein, for the Treatment of Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT04123886
- Acronym / sponsor ID
- CLO-SCB-313-CHN-002
- Conditions
- Malignant Pleural Effusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sichuan Clover Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 11 Oct 2019 (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.
To evaluate the safety and tolerability of single dose of SCB-313 by intrapleural injection.To evaluate the safety and tolerability of repeated dose of SCB-313 by intrapleural injection once a day for 3 days, and to determine the maximum tolerated dose (MTD) of SCB-313.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCB-313 | Experimental | Drug: SCB-313 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically or cytologically confirmed cancer of any primary tumor type.
- Malignant pleural effusion requiring drainage that is histologically or cytologically confirmed;
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2. Patients with an ECOG performance status of 3 may be included if the Investigator determines that removal of pleural fluid would improve their performance status to 2 or better.
- Life expectancy of at least 8 weeks.
- Age ≥18 years and ≤ 75 years;.
Key exclusion criteria (18 listed)
- Significantly loculated pleural effusions not amenable to drainage or patient is unlikely to benefit from intrapleural therapy.
- Any anti-tumor drug other than the systemic anti-tumor therapy that the subject has stably used and any treatment that may have an effect on the control of pleural effusions. Prior therapy with monoclonal antibody should be stopped per Investigators judgement making sure delayed side effects will not interfere with the DLT evaluation period after SCB-313 therapy.
- Acute or chronic infection (such as tuberculosis) requiring antiviral or intravenous antibiotics within 2 weeks prior to enrollment.
- Clinical unstable or uncontrolled concomitant hematologic, cardiovascular, pulmonary, hepatic, renal, pancreatic, or endocrine diseases.
- History of gross hemoptysis (>2.5 mL) within 3 months prior to enrollment.
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 |
|---|---|---|
| SCB-313SCB-313 Intrapleural injection, once daily. Single dose on Day 1 in Cycle 0 followed by 7-day safety assessment, then dose on Day 1,2,3 in Cycle 1 followed by 21-day observation . | Drug | SCB-313 |
Primary outcome
DLT
Time frame: 28 days after first dosing
Dose Limiting Toxicity
2 secondary outcomes
AEs
Time frame: 28 days after first dosing
Immunogenicity
Time frame: up to 28 days after first dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCB-313 in people with Malignant Pleural Effusion, run by Sichuan Clover Biopharmaceuticals, Inc. 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 20 inclusion and 18 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: finished, as of the sponsor's last update on 6 May 2022. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 28 days after first dosing). 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 May 2022.