Drugs / CEB-01
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04619056 | Jun 2020 → Nov 2025 | soft tissue sarcoma | CEBIOTEX | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06538857 | Aug 2024 → Sep 2028 expected | exocrine pancreatic carcinoma | CEBIOTEX | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-04-23 | CEBIOTEX | Results First-in-human study of CEB-01 in retroperitoneal sarcoma cebiotex.com ↗
We are proud to announce the publication of our latest clinical results in Annals of surgical oncology, detailing the first-in-human study of CEB-01, a novel biodegradable membrane for the local delivery of SN-38 after tumour resection. |
| 2025-09-16 | CEBIOTEX | Regulatory Cebiotex obtains EMA ODD for CEB-01 in Pancreatic Cancer cebiotex.com ↗
CEB-01, our lead product for local post-surgical cancer treatment, has been granted Orphan Drug Designation (ODD) status by the EMA for the treatment of pancreatic cancer (PC), a disease with one of the lowest survival rates and few effective treatment options. |
| 2025-06-18 | CEBIOTEX | Regulatory CEBIOTEX receives approval to initiate a paediatric phase II clinical trial for locally resectable abdominal tumours cebiotex.com ↗
We are excited to share that the clinical trial to evaluate the safety, pharmacokinetics and efficacy of CEB-01 in locally resectable abdominal tumours of children has been green lighted by the regulatory authorities. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-23 | CEBIOTEX | First-in-human study of CEB-01 in retroperitoneal sarcoma cebiotex.com ↗ |
| 2025-09-16 | CEBIOTEX | Cebiotex obtains EMA ODD for CEB-01 in Pancreatic Cancer cebiotex.com ↗ |
| 2025-06-18 | CEBIOTEX | CEBIOTEX achieves a key milestone: the launch of in-house GMP-certified manufacturing facilities to support the production of CEB-01 cebiotex.com ↗ |
| 2025-06-18 | CEBIOTEX | CEBIOTEX receives approval to initiate a paediatric phase II clinical trial for locally resectable abdominal tumours cebiotex.com ↗ |
| 2025-03-31 | CEBIOTEX | Launch of First Pancreatic Cancer Clinical Trial with CEB-01 in Spain cebiotex.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CEB-01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04619056 ↗ |
| Known as | CEB-01 PLGA membrane | “First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma” NCT04619056 ↗ |
| Modality | Other / unclassified | “CEB-01 is a polymeric drug with a delivery system loaded with SN-38” NCT04619056 ↗ |
| Route | Other | “will be placed in the surgical bed at the time of tumor resection.” NCT04619056 ↗ |