AzTrials
AzTrials

Locally Advanced Soft Tissue SarcomaPhase 1NCT04619056

First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma

A Phase 1 study testing CEB-01 membrane loaded with SN-38 in people with Locally Advanced Soft Tissue Sarcoma and Recurrent Soft Tissue Sarcoma, run by CEBIOTEX at 5 sites in Spain.

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

This is an open label, first-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CEB-01 membrane loaded with SN-38
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
5 sitesSpain
Study dates
3 Jun 2020to 28 Nov 2025
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

  • Age >18 years.
  • Histologically confirmed diagnosis of locally advanced (T3 -T4, American Joint Committee on Cancer (AJCC)/primary tumor, regional lymph nodes, and distant metastases staging system (TMN) 8th Edition) and/or relapsed (any) retroperitoneal soft tissue sarcoma (liposarcoma, leiomyosarcoma, a solitary fibrous tumor (SFT), pleomorphic sarcoma, or a malignant nerve sheath tumor). Patients with local advanced (T3 -T4,AJCC/TMN 8th Edition) and/or relapse and metastatic disease who are candidates for local surgery without option of systemic treatment, are also eligible for the trial.
  • Pathology specimens available for centralized review. Submission of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central reviewing is required; if a FFPE block cannot be provided, then 10 unstained, positively-charged slides of 4-5 um thickness must be submitted.
  • Size of tumor (visible or previously inadequately resected) >5 cm at instrumental staging (CT, MRI).
  • Normal liver, renal, hematological, and cardiac function as defined by biochemical and hematological parameters as follows: Hb >11 g/dL, platelets >100.000/mm3, White Blood Cells (WBC) >3000/mm3, neutrophil count >1500/mm3, albumin >3.0 g/dl, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <2.5 times the upper limit of normality (ULN), bilirubin <2 times the ULN, creatinine <1.5 mg/dl or creatinine clearance > 60 ml/min.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status <2.
Show all 11Show fewer
  • No concomitant radiotherapy or chemotherapy planned.
  • Life expectancy greater than 6 months.
  • Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.
  • Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 3 months after surgery.
  • Ability to understand and the willingness to sign a written informed consent document; subject has signed an Informed Consent Form (ICF) prior to any screening procedures and is able to comply with protocol requirements.

Who cannot join

  • Pregnancy or lactation. Note: Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.
  • Other malignancies within past 5 years, with the exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent.
  • Serious psychiatric disease that precludes informed consent or limits compliance
  • Medical condition limiting survival to less than 6 months.
  • Uncontrolled bacterial, viral or fungal infection.
  • Active viral hepatitis or chronic liver disease.
Show all 12Show fewer
  • Impossibility of ensuring adequate follow-up.
  • Contraindication to magnetic resonance imaging (MRI), including presence of a pacemaker or an aneurysm clip, severe claustrophobia, a known reaction to the gadolinium contrast dye, or body weight that could interfere with the feasibility of a MRI.
  • Major surgery within 14 days prior to starting study drug or still in recovery after experiencing surgical complications; neither tumor biopsy nor central line insertion are considered a major surgery.
  • Unable or unwilling to stop the use of herbal supplements; the use of nutritional supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation.
  • Other relevant concomitant illnesses.
  • Patients previously treated with Irinotecan.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital General Universitario Gregorio Marañón

    Madrid, Madrid, 28007

  • Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital Universitario y Politécnico La Fe

    Valencia, Valencia, 46026

Other trials in Spain

About this study

Official title: First-in-man Clinical Trial to Assess Safety and Tolerability of CEB-01 PLGA Membrane in Patients With Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma After Surgery

This is an open label, first-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery.

The trial will be conducted in 3 dose-escalation cohorts (3 patients each, enrolling patients one by one, after 4 weeks of observation and agreement of Scientific Committee and DMC) and in an expansion cohort, using the highest safe and tolerable dose. The study will follow a 3+3 modified design; dose escalation will follow a modified Fibonacci method. CEB-01 carrying a SN-38 dose between 9 and 36 mg will be placed in the surgical bed at the time of tumor resection.

Read the detailed description

CEB-01 is a poly(lactic-co-glycolic acid) (PLGA) polymeric drug with a delivery system loaded with SN-38, and will be placed in the surgical bed at the time of tumor resection.

CEB-01 carrying a SN-38 dose between 9 and 36 mg will be administered. CEB-01 will be placed on all surfaces that were in contact with and/or were infiltrated by the tumor.

Confirmatory central reviewing of diagnosis will be performed for all patients, using tumor samples obtained during surgery; additionally, patients will also be included according to local Pathological Anatomy (PA) diagnosis.

Patients will be followed-up once every week during the first 8 weeks of the study, and then every 2 weeks up to 12 weeks after implantation of CEB-01. Thereafter, follow-up schedule will be as per normal practice until study completion.

Efficacy assessment will be performed by Magnetic Resonance Imaging (MRI) [Computed tomography (CT) scan and Positron Emission Tomography (PET-CT) are also allowed] according to RECIST 1.1 criteria. Baseline image determination will be performed at week 12 (±3 days) after surgery; if the image analysis is not conclusive due to wound healing in the tumor bed, it will be repeated on week 16 (±3 days) post-surgery, and every 12 weeks thereafter.

A pharmacokinetic assessment of SN-38 will be performed in all patients, and the Cmax, Tmax, half-life, and area under the time-drug concentration curve (AUC) of the drug will be determined. Blood samples will be collected at baseline and at 8 time points after CEB-01 implantation.

Assessment of adverse events, safety, and toxicity will be performed according to the Common Terminology Criteria for Adverse Events (CTCAE - version 5.0) at each patient visit from the time of Informed Consent until the end of the study.

Quality of Life based on EORTC Quality of Life Questionnaire (QLQ) 30 will be measured prior surgery, at month 1 and month 3.

Being tested
CEB-01 membrane loaded with SN-38
Keywords
Soft tissue sarcoma, Retroperitoneal, Recurrent or locally advanced, CEB-01 PLGA membrane, SN-38, Local drug delivery system
Medical subject headings
Sarcoma, Recurrence

What participants receive

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

  • CEB-01 membrane loaded with SN-38Drug

    CEB-01 is a polymeric drug with a delivery system loaded with SN-38, and will be placed in the surgical bed at the time of tumor resection.

Study groups in NCT04619056
Study groupRoleWhat they receive
Cohort 1ExperimentalCEB-01 with total SN-38 dose: 9 mg
Receives: Drug: CEB-01 membrane loaded with SN-38
Cohort 2ExperimentalCEB-01 with total SN-38 dose: 18 mg
Receives: Drug: CEB-01 membrane loaded with SN-38
Cohort 3ExperimentalCEB-01 with total SN-38 dose: 36 mg
Receives: Drug: CEB-01 membrane loaded with SN-38

What is being measured

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

  1. Recommended Doses for Phase II (Maximum tolerated dose)

    The number of patients experiencing dose limiting toxicities during the Dose Limiting Toxicities (DLT) observation period of 2 weeks.

    Measured: Through 2 weeks

Secondary outcomes (6)

  1. Frequency of Adverse Events (AEs) (Safety)

    Frequency of adverse events reported classified by type and severity.

    Measured: Through study completion, average 2 years

  2. Frequency of Treatment Related Adverse Events (TRAEs) (Toxicity)

    Frequency of treatment related adverse events reported classified by type and severity.

    Measured: Through study completion, average 2 years

  3. Time to local relapse (TTLR)

    Time from the start of treatment to the date of local relapse according to the RECIST 1.1 criteria, or death due to any cause. Those patients who are alive and have not relapsed at the last follow-up, will be censored at the date of the last follow-up.

    Relapse definition: For patients in which R0 is obtained by surgery, relapsed should be considered when disease reappears with size > 1 cm (measurable disease). For patients with R1 or R2, RECIST 1.1 guideline should be used for disease progression definition.

    Measured: Through study completion, average 2 years

  4. Progression Free Survival (PFS)

    Time from the start of treatment to the date of the first progression according to the RECIST 1.1 criteria, or death due to any cause. Those patients who are alive and have not progressed at the last follow-up, date of progression will be censored at the date of the last follow-up.

    Measured: Through study completion, average 2 years

  5. Overall Survival (OS)(until 24 months of Follow Up (FU))

    Median of overall survival. Time from the start of the trial treatment to the date of exitus for any cause. In those patients who are alive at the last follow-up, OS will be censored by the date of the last follow-up in which the patient was alive.

    Measured: Through study completion, average 2 years

  6. Quality of life: EORTC QLQ 30

    Questionnaire developed and validated to assess the quality of life of cancer patients.

    Measured: Prior to surgery, at month 1 and month 3 after surgery

Timeline

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

  1. First posted6 Nov 2020
  2. Study start3 Jun 2020
  3. Primary completion28 Nov 2025
  4. Study completion28 Nov 2025

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
Randomised
Intervention model
Parallel groups
Model description
This is an open label, first-in-human clinical trial that will be conducted in 3 dose-escalation cohorts (3-6 patients each) and in an expansion cohort, at the highest dose determined to be safe and tolerable. CEB-01 loaded with a SN-38 dose between 9 and 36 mg will be allocated to each patient.
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619056
Sponsor's protocol ID
CEB-01-RLS01-CT
Other IDs
2018-001026-25, 2018
Status last verified
May 2026
First submitted
30 Oct 2020
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sebio A, Gonzalez JA. ASO Author Reflections: Preventing Local Recurrence After Surgery in Retroperitoneal Sarcoma with CEB-01, a SN-38-Releasing Membrane. Ann Surg Oncol. 2026 Aug;33(8):7714-7715. doi: 10.1245/s10434-026-19638-6. Epub 2026 Apr 15. No abstract available.

    PubMed 41984421

  • Gonzalez JA, Sebio A, Martin-Broto J, Hindi N, Villarejo-Campos P, Jimenez M, Diaz-Beveridge R, Orbis Castellanos JF, Lopez Andujar R, Alvarez Alvarez R, Asencio JM, Serrano C, Rodriguez Conde N, Castro Boix S, Krauel L, Colom Codina H, Tornero Garcia JA, Lopera de Llanos E, Huguet Ninou A, Perez Campos A, Gruber AK, Lopez Pousa A. ASO Visual Abstract: First-in-Human Study of CEB-01: Novel Loco-Regional SN-38-Releasing Membrane to Prevent Local Recurrence in Retroperitoneal Sarcomas. Ann Surg Oncol. 2026 Aug;33(8):7717-7718. doi: 10.1245/s10434-026-19614-0. No abstract available.

    PubMed 41984420

  • Gonzalez JA, Sebio A, Martin-Broto J, Hindi N, Villarejo-Campos P, Jimenez M, Diaz-Beveridge R, Orbis Castellanos JF, Lopez Andujar R, Alvarez Alvarez R, Asencio JM, Serrano C, Rodriguez Conde N, Castro Boix S, Krauel L, Colom Codina H, Tornero Garcia JA, Lopera de Llanos E, Huguet Ninou A, Perez Campos A, Gruber AK, Lopez Pousa A. First-in-Human Study of CEB-01: Novel Loco-Regional SN-38-Releasing Membrane to Prevent Local Recurrence in Retroperitoneal Sarcomas. Ann Surg Oncol. 2026 Aug;33(8):7677-7687. doi: 10.1245/s10434-026-19487-3. Epub 2026 Apr 17.

    PubMed 41998462

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CEB-01 membrane loaded with SN-38 in people with Locally Advanced Soft Tissue Sarcoma and Recurrent Soft Tissue Sarcoma, run by CEBIOTEX at 5 sites in Spain.

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 11 inclusion and 12 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 12 May 2026. 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 Spain. 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?

Recommended Doses for Phase II (Maximum tolerated dose) (time frame: Through 2 weeks). 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 NCT04619056, which also lists 3 linked publications.

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 May 2026.

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