Trial reportAnnals of surgical oncology2026
First-in-Human Study of CEB-01: Novel Loco-Regional SN-38-Releasing Membrane to Prevent Local Recurrence in Retroperitoneal Sarcomas.
Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04619056 (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), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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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
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Authors and funding
22 authors.
Funding
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Abstract
backgroundRetroperitoneal sarcoma (RPS) resection remains challenging, with up to 50% of patients developing local recurrence and a 5-year survival rate of 50%. CEB-01, designed for local and controlled SN-38 delivery postresection, may increase local control and survival rates. MATERIALS AND
methodsCEB-01 is a first-in-human, multicenter trial following a 3+3 dose escalation design and expansion cohort conducted in six centers in Spain. CEB-01 was implanted at three dose levels of SN-38: 9, 18, and 36 mg. The objectives were to establish the recommended phase 2 dose (RP2D) and evaluate its safety, efficacy, and pharmacokinetics.
resultsFrom July 2020 to November 2023, 14 patients were included: 10 males, with a median age of 63 years (range: 40-76), mostly with dedifferentiated (50%) and well-differentiated liposarcoma (35.7%), and R0 (79%) and R1 (21%) postsurgical margins. No dose-limiting toxicities were observed, and the RP2D was set at 18 mg. With a median follow-up of 9.1 months (range: 1-21), all patients at RP2D were recurrence-free and alive. Grade ≥ 3 adverse events were reported in just one patient treated with RP2D. The pharmacokinetic profile of SN-38 showed substantially lower C
conclusionsCEB-01 at 18 mg exhibited a tolerable safety profile and preliminary efficacy against postsurgery recurrence in patients with RPS. These results warrant further clinical investigations of this type of tumor. Clinical trial identification: EU CT: 2024-516971-34-00; clinicaltrials.gov: NCT04619056.
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