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Peritoneal MalignanciesPhase 1NCT03443674

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Peritoneal Malignancies

A Phase 1 study testing SCB-313 in people with Peritoneal Malignancies, run by Clover Biopharmaceuticals AUS Pty at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and PK/PD of SCB-313 (recombinant human TRAIL-Trimer fusion protein) administered twice weekly for 2 weeks via IP bolus injection for the treatment of patients with peritoneal malignancies, including but not limited to peritoneal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peritoneal Malignancies
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
7 participants
Where
5 sitesAustralia
Study dates
18 Jun 2018to 26 Aug 2021
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

  • Histologically or cytologically confirmed peritoneal malignancies after failure or refusal of all approved therapies, and no better option available in the Investigator's opinion.
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2 (Patients with ECOG score of 3 might be allowed to enter this trial per Investigator's judgment)
  • Life expectancy of at least 8 weeks
  • Age ≥18 years
  • Body mass index ≥17.0 kg/m2
  • Adequate hematological function, defined as:
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  • Platelet count ≥ 75,000/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)
  • Adequate renal function, defined as serum creatinine ≤2.0 times ULN and creatinine clearance >45 mL/minute
  • Adequate liver function, defined as:
  • Aspartate aminotransferase and alanine aminotransferase ≤3 times ULN for patients without liver metastases, or ≤5 times ULN in the presence of liver metastases
  • Bilirubin ≤1.5 times ULN, unless patient has known Gilbert's syndrome
  • Female patients of childbearing potential (excluding women who have undergone surgical sterilization or menopause. Menopause is defined as the status where no menstrual periods continue for 1 year or more without any other medical reasons), are eligible if they have negative serum pregnancy testing within 7 days prior to first dosing and are willing to use an effective method of birth control/contraception to prevent pregnancy until 6 months after discontinuation of the 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 the SCB-313.
  • Note: Contraceptive methods that are considered highly effective are, for example, total abstinence, an intrauterine device, a double barrier method (such as condom plus diaphragm with spermicide), a contraceptive implant, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release), or have a vasectomized partner with confirmed azoospermia.

Who cannot join

  • Acute or chronic infection (such as tuberculosis) requiring antiviral or intravenous (IV) antibiotics within 2 weeks prior to enrollment.
  • Symptoms or signs (including laboratory tests) of clinically significant concomitant hematologic, cardiovascular, pulmonary, hepatic, renal, pancreatic, or endocrine diseases.
  • Residual adverse events (AEs) > Grade 2 from previous treatment.
  • 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.
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  • Left ventricular ejection fraction <40% as determined by echocardiography performed at screening or within 90 days prior to enrollment.
  • Prior anti-tumor therapy (chemotherapy) within 2 weeks, hormone therapy or palliative extra-abdominal radiotherapy within at least 1 week, or small-molecule targeted therapy within 5 half-lives prior to enrollment. Prior therapy with monoclonal antibody should be stopped after Investigator's judgement making sure delayed side effects will not interfere with the dose limiting toxicity (DLT) evaluation period after SCB-313 therapy.
  • Major surgery within 4 weeks prior to enrollment.
  • Patient with ileus within 30 days prior to screening.
  • Positive serology test for human immunodeficiency virus Type 1 and 2 or known history of other immunodeficiency disease.
  • Live vaccine within 2 weeks prior to enrollment.
  • Scheduled participation in another clinical study involving an investigational product or device during the course of this study.
  • Previous treatment with a TRAIL-based therapy or death receptor (DR) 4/5 agonist therapy.
  • Known or suspected hypersensitivity to any component of the SCB-313.
  • Any further condition which, according to the Investigator, may result in undue risk of the patient by participating in the present study.
  • Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Orange Health Service

    Orange, New South Wales, 2800

  • John Flynn Private Hospital

    Tugun, Queensland, 4224

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

About this study

Official title: A Phase I Study Evaluating Safety, Tolerability, and Pharmacokinetics of SCB-313, a Fully-Human TRAIL-Trimer Fusion Protein, for the Treatment of Peritoneal Malignancies

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and PK/PD of SCB-313 (recombinant human TRAIL-Trimer fusion protein) administered twice weekly for 2 weeks via IP bolus injection for the treatment of patients with peritoneal malignancies, including but not limited to peritoneal carcinomatosis, malignant ascites, pseudomyxoma peritonei, and peritoneal mesothelioma.

Being tested
SCB-313

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCB-313Drug

    Also called recombinant human TRAIL-Trimer fusion protein

    Lyophilized powder in a single-use vial

Study groups in NCT03443674
Study groupRoleWhat they receive
SCB-313ExperimentalDose escalation cohorts--10mg, 20mg, 40mg, 80mg, 160mg. For each cohort: administered twice weekly (eg.. Monday and Thursday or Tuesday and Friday) for 2 weeks (Days 1, 4, 8, and 11) by IP bolus injection.
Receives: Drug: SCB-313

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability: Occurrence of serious adverse events (SAEs) and/or TEAEs

    Regardless of causality or relationship to SCB-313 graded using National Cancer Institute Common Terminology Criteria for Adverse Events Version.4.03 (NCI CTCAE v4.03).

    Measured: Up to 41 days after start of treatment

Secondary outcomes (8)

  1. Immunogenicity: Occurrence of binding and neutralizing anti-SCB-313 antibodies

    Occurrence of binding and neutralizing anti-SCB-313 antibodies

    Measured: Up to 41 days after start of treatment

  2. Pharmacokinetics (Cmax)

    Maximum serum concentration

    Measured: Up to 12 days after start of treatment

  3. Pharmacokinetics (Cmax/D)

    Dose-normalized Cmax of SCB-313

    Measured: Up to 12 days after start of treatment

  4. Pharmacokinetics (tmax)

    Time to Cmax of SCB-313

    Measured: Up to 12 days after start of treatment

  5. Pharmacokinetics ([AUC]0-24)

    Area under SCB-313 concentration time curve from zero to 24 hours

    Measured: Up to 12 days after start of treatment

  6. Pharmacokinetics (AUC0-24/D)

    Dose-normalized AUC0-24 of SCB-313

    Measured: Up to 12 days after start of treatment

  7. Pharmacokinetics ((AUC0-last))

    Area under curve from time 0 on Day 1 to the last quantifiable concentration time point

    Measured: Up to 12 days after start of treatment

  8. Pharmacokinetics (Ctrough)

    Trough concentration of SCB-313 at each predose and at 24 hours after the last dose

    Measured: Up to 12 days after start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2018
  2. Study start18 Jun 2018
  3. Primary completion30 May 2021
  4. Study completion26 Aug 2021

Resources

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03443674
Sponsor's protocol ID
CLO-SCB-313-001
Status last verified
Oct 2021
First submitted
7 Jan 2018
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCB-313 in people with Peritoneal Malignancies, run by Clover Biopharmaceuticals AUS Pty at 5 sites in Australia.

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 17 inclusion and 17 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 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. 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?

Safety and Tolerability: Occurrence of serious adverse events (SAEs) and/or TEAEs (time frame: Up to 41 days after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443674.

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 19 Oct 2021.

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