AzTrials
AzTrials

Malignant AscitesPhase 1NCT04051112

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

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

Completed

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

Official record
Search all trials

Trial summary

1. The safety and tolerability of single-dose of SCB-313 will be evaluated by intraperitoneal injection; 2. The safety and tolerability of repeated-dose of SCB-313 will be evaluated by intraperitoneal injection once a day for 3 days, and the maximum tolerated dose (MTD) of SCB-313 will be determined; Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Ascites
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
13 participants
Where
1 siteChina
Study dates
28 Sep 2019to 21 Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed as malignant solid tumor.
  • Malignant ascites requiring puncture drainage evaluated by investigators, defined as:
  • if tumor cells are detectable in the ascites ,
  • if previous surgical operation reveals extensive abdominal cavity metastasis,
  • if there is image evidence of extensive metastasis in the abdominal cavity,
  • if it is determined by ascites routine and ascites biochemical examination as exudate.
Show all 17Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 3.
  • Life expectancy of at least 12 weeks.
  • Age ≥ 18 years.
  • Body weight ≥ 45 kg and body mass index (BMI) >17 kg/m2
  • Adequate hematological function, defined as: (a) Platelet count ≥100×109/L, (b) Prothrombin time and activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN), (c) Absolute neutrophil count ≥1.5×109/L, and (d) Hemoglobin ≥ 9 g/dL.
  • Adequate renal function, defined as serum creatinine ≤ 2.0 times ULN and creatinine clearance > 50 mL/minute.
  • Adequate liver function, defined as: (a) Aspartate aminotransferase and alanine aminotransferase ≤ 3 times ULN for patients without liver metastases, or ≤ 5 times ULN in the presence of liver metastases, and (b) Bilirubin ≤ 2.0 times ULN, unless patient has known Gilberts syndrome.
  • Albumin ≥ 2.8 g / dL (patient can use albumin to meet the standard)
  • If the serum pregnancy test of a female patient with fertility is negative within 7 days prior to the initial administration, and she is willing to use effective birth control/contraception method for contraception within 6 months after discontinuation of SCB-313.( Female patients with fertility exclude women who have undergone sterilization or menopause, which is defined as a menstrual period that lasts for one year or more without any other medical reason.) All male and female patients with reproductive potential must agree to take effective contraceptive measures during the study period and within 6 months after discontinuation of SCB-313.
  • Note: Contraceptive methods considered to be effective include: complete abstinence, intrauterine devices, double barrier contraceptive methods (such as condom plus spermicide diaphragm), implanted contraceptives, hormonal contraceptives (contraceptives, implants agent, transdermal patch, hormonal vaginal device or injection for extended release), or the partner has removed the vas deferens and confirmed that it is azoospermia
  • Willing to attend follow-up visits according to study protocol.

Who cannot join

  • Loculated ascites not amenable to full drainage or benefit from abdominal treatment
  • Acute or chronic infection (such as tuberculosis) requiring antiviral or intravenous antibiotics within 2 weeks prior to enrollment.
  • Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression.
  • Residual adverse events (AEs) ≤ Grade 1 from previous treatment except alopecia.
  • 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 >480 msec at baseline.
Show all 18Show fewer
  • Uncontrolled hypertension defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg confirmed upon repeated measures.
  • Left ventricular ejection fraction < 50% as determined by echocardiography performed at screening
  • Hormone therapy or palliative extra abdominal radiotherapy within 1 week, prior anti-tumor therapy (chemotherapy) within 2 weeks, or other test drug within 4 weeks prior to enrollment.
  • Major surgery within 4 weeks prior to enrollment.
  • Patient with ileus within 30 days prior to screening.
  • Known portal vein obstruction (due to either prehepatic, hepatic, or posthepatic condition) which per Investigators judgement, is the primary or significant cause of ascites.
  • Positive serology test for human immunodeficiency virus type 1 and 2, or known history of other immunodeficiency disease.
  • Uncontrolled active hepatitis.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200126

Other trials in China

About this study

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

  1. The safety and tolerability of single-dose of SCB-313 will be evaluated by intraperitoneal injection;
  2. The safety and tolerability of repeated-dose of SCB-313 will be evaluated by intraperitoneal injection once a day for 3 days, and the maximum tolerated dose (MTD) of SCB-313 will be determined;
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

    10mg group: Intraperitoneal injection single dose on Day 0, safety observation for 7 days, then 3 continuous doses on Day7, Day8, Day9, 21 days for 1 cycle

Study groups in NCT04051112
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. MTD

    MTD for single and multiple doses of SCB-313

    Measured: 28 days after first dosing

  2. DLT

    Dose Limiting Toxicity (DLT)

    Measured: 28 days after first dosing

  3. AE/SAE

    The severity of the adverse events associated with SCB-313 treatment, the incidence of serious adverse events (SAE), and the severity and incidence of adverse events (TEAE) during the DLT-observation period developed in patients, and the classification is based on the National Cancer Institute General Adverse Event Terminology

    Measured: 28 days after first dosing

Secondary outcomes (5)

  1. Immunogenicity

    Occurrence of binding and neutralizing anti-SCB-313 antibodies

    Measured: Up to 28 days after first dosing

  2. Pharmacokinetics (Cmax)

    Maximum SCB-313 concentration

    Measured: Pre-dose(0 hour[hr]), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr post-dose on Day 1 and Day 10

  3. Pharmacokinetics (tmax)

    Time to Cmax of SCB-313

    Measured: Pre-dose(0 hour[hr]), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr post-dose on Day 1 and Day 10

  4. Pharmacokinetics ([AUC]0-24)

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

    Measured: Pre-dose(0 hour[hr]), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr post-dose on Day 1 and Day 10

  5. Pharmacokinetics (AUC 0-inf)

    Area under curve from time 0 extrapolated to infinity

    Measured: Pre-dose(0 hour[hr]), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr post-dose on Day 1 and Day 10

Timeline

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

  1. First posted9 Aug 2019
  2. Study start28 Sep 2019
  3. Primary completion24 Dec 2021
  4. Study completion21 Apr 2022

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
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04051112
Sponsor's protocol ID
CLO-SCB-313-CHN-001
Status last verified
May 2022
First submitted
4 Aug 2019
Last updated
6 May 2022
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 Malignant Ascites, 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 17 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?

MTD (time frame: 28 days after first dosing). The study lists 3 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 NCT04051112.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in