Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age24-18
SponsorITM Solucin GmbH

About this trial

The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \<18 years of age with somatostatin receptor (SSTR)-positive tumors.

Eligibility criteria

Qualifiers

Participants aged ≥ 2 years and < 18 years

Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.

Tumor which is relapsed or is refractory to at least one line of previous therapy

Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample

Disqualifiers

Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or excipients

Previous history of acute leukemia unless in remission for at least two years

Extensive bone/bone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells/kg

Patients who have received previous systemic targeted RPT

Trial design

Treatments tested in this trial

  • Lutetium Lu 177-Edotreotide
  • Amino Acid Solution

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators