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Peritoneal CarcinomatosisPhase 1NCT04047771

A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis

A Phase 1 study testing SCB-313 in people with Peritoneal Carcinomatosis, run by Sichuan Clover Biopharmaceuticals, Inc. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To evaluate the safety and tolerability of SCB-313 in patients with peritoneal carcinomatosisa, to determine the maximum tolerated dose (MTD) and/or extended study recommended dose (RDE) for SCB-313 intraperitoneal injection, providing a basis for dosing regimen and dose choosing in clinical trial subsequently. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Peritoneal Carcinomatosis
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
10 participants
Where
1 siteChina
Study dates
10 Sep 2019to 5 May 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

  • Be able to understand and voluntarily sign written informed consent.
  • Male or female subjects, age ≥18, ≤75 years.
  • Confirmed by histopathology or cytopathology, any primary or secondary malignant peritoneal carcinomatosis subject.
  • Progression after standard treatment, or inability to tolerate standard treatment, or no standard treatment.
  • ECOG status 0 to 2 or KPS status > 60
  • CT-PCI (Peritoneal Carcinomatosis Index) status ≥ 15
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  • Life expectancy of at least 3 months.
  • No serious hematologic, hepatic, renal dysfunction, comply with the following laboratory test results:
  • Hematology: white blood cell count >3*109/L, absolute neutrophil count ≥1.5*109/L, platelets > 75*109/L, hemoglobin > 90 g/L.
  • Liver function: aspartate aminotransferase and alanine aminotransferase ≤ 3 times ULN, Alkaline phosphatase (ALP) ≤ 2.5 times ULN; serum total bilirubin (TBIL) ≤ 1.5 times ULN.
  • Renal function: Creatinine clearance calculated according to the Cockcroft-Gault formula ≥ 50 mL/min.
  • All adverse events from previous system anticancer treatment return to baseline or ≤ grade 1 (except for alopecia and vitiligo, neuropathy which induced by previous anticancer therapy status stable or ≤ grade 2).
  • Male or female subjects undergo effective contraception during treatment and within 6 months after last dose.

Who cannot join

  • Previous treatment with TRAIL pathway drug.
  • Malignant cancer diseases other than malignant peritoneal carcinomatosis in this study (Exceptions include: a cured malignant cancer without relapse within 3 years prior to the study enrollment, completely resected basal cells and squamous cell skin cancer, and any type of carcinoma in situ).
  • Primary lesion invades the central nervous system (CNS) with symptoms develop, status unstable or require high dose steroids (e.g. dexamethasone ≥ 10 mg or equivalent dose) to control.
  • Abnormal HBV examination, anti-HCV positive, anti-HIV antibody positive or other serious infections requiring systemic treatment within 4 weeks prior to first dosing (e.g. virus, bacteria or fungus).
  • Use the following concomitant therapy before dosing:
  • Use drug that prolongs the QT interval and/or associated with the risk of torsades de pointes ventricular tachycardia (TdP) within 7 days prior to first dosing.
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  • Use amiodarone within 90 days prior to first dosing.
  • Impaired heart function or clinically significant cardiovascular disease, including any of the following:
  • Cerebrovascular accident/stroke (within 6 months prior to enrollment).
  • Myocardial infarction (within 6 months prior to enrollment).
  • Unstable angina, congestive heart failure (New York Heart Association grade ≥ II) or severe arrhythmia requiring medication (including QT/QTc interval extension >480 msec, installation of pacemakers, etc.).
  • Left ventricular ejection fraction < 50% as determined by echocardiography.
  • Active bleeding history or gastrointestinal perforation risk within 4 weeks before enrollment, or not healed from recent surgery.
  • Received anticancer treatment within following specified time before first dosing:
  • Received medical treatment ≤ 4 weeks or 5 times known drug half-life (whichever is longer).
  • Underwent major surgery within ≤ 4 weeks before first dosing.
  • Residual adverse events from previous treatment≥ grade 2.
  • Known to have alcohol and/or drug dependence.
  • Previous clear history of neurological or mental disorders, such as epilepsy, poor compliance
  • Female subjects with positive blood pregnancy tests or during lactation.
  • Previously allergic to macromolecular protein drugs or proteins or Quincke's edema (Kunke edema, also known as angioedema) or allergic to any component of the SCB 313.
  • Known history of infection with human immunodeficiency virus, or other acquired, innate immune deficiency diseases, or history of organ transplantation.
  • Vaccination within ≤ 4 weeks prior to first dosing, or planning live vaccination.
  • For other reasons according to investigators, not suitable for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Shijitan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100038

Other trials in China

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 Subjects With Peritoneal Carcinomatosis

To evaluate the safety and tolerability of SCB-313 in patients with peritoneal carcinomatosisa, to determine the maximum tolerated dose (MTD) and/or extended study recommended dose (RDE) for SCB-313 intraperitoneal injection, providing a basis for dosing regimen and dose choosing in clinical trial subsequently.

Being tested
SCB-313
Medical subject headings
Peritoneal Neoplasms

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

    Intraperitoneal injection, 3 doses on D1,D4,D7，21 days for 1 cycle

Study groups in NCT04047771
Study groupRoleWhat they receive
SCB-313ExperimentalNot described
Receives: Drug: SCB-313

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    DLT

    Measured: 21 days after first dosing

  2. Occurrence of adverse events (AEs) and serious adverse events (SAEs)

    AEs

    Measured: 21 days after first dosing

Secondary outcomes (5)

  1. Immunogenicity

    Occurrence of binding and neutralizing anti-SCB-313 antibodies

    Measured: 28 days after last dosing

  2. Pharmacokinetics (Cmax)

    Maximum SCB-313 concentration

    Measured: Up to 24 hours after dosing

  3. Pharmacokinetics (tmax)

    Time to Cmax of SCB-313

    Measured: Up to 24 hours after dosing

  4. Pharmacokinetics ([AUC]0-24)

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

    Measured: Up to 24 hours after dosing

  5. Pharmacokinetics (AUC 0-inf)

    Area under curve from time 0 extrapolated to infinity

    Measured: Up to 24 hours after dosing

Timeline

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

  1. First posted7 Aug 2019
  2. Study start10 Sep 2019
  3. Primary completion5 May 2022
  4. Study completion5 May 2022

Why it stopped: terminated

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04047771
Sponsor's protocol ID
CLO-SCB-313-CHN-003
Status last verified
Apr 2023
First submitted
5 Aug 2019
Last updated
12 Apr 2023
Results posted
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 Carcinomatosis, 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 13 inclusion and 24 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: stopped early, as of the sponsor's last update on 12 Apr 2023. 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 was stopped early (reason given: terminated). Results are not available in the source record.

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?

Dose Limiting Toxicity (DLT) (time frame: 21 days after first dosing). 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?

On the ClinicalTrials.gov record for NCT04047771.

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 12 Apr 2023.

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