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

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.

Trial Details

NCT ID

NCT06441331

Phase

PHASE1

Sponsor

ITM Solucin GmbH

Status

RECRUITING

Cancer Type

Sarcoma

Interventions

Lutetium Lu 177-Edotreotide
Amino Acid Solution

Locations (sample)

Palo Alto, California, United States|37.44188,-122.14302
San Francisco, California, United States|37.77493,-122.41942
Cincinnati, Ohio, United States|39.12711,-84.51439
Philadelphia, Pennsylvania, United States|39.95238,-75.16362
Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

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

For full eligibility, visit ClinicalTrials.gov.

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