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

Recruiting Phase 1 Interventional Study
Somatostatin Receptor Positive NETs Lymphoma Solid Tumor CNS Tumors Rhabdomyosarcoma Peripheral Primitive Neuroectodermal Tumor GIST
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
24 Months – 18
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
ITM Solucin GmbH · Industry
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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.

Trial Locations
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Eligibility Criteria
Key Inclusion 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 immunohistochemistr…
Contacts

Shahanaz Rahman

+4989 32989866000

kinlet@itm-radiopharma.com

CONTACT

Serhii Melnyk, MD

kinlet@itm-radiopharma.com

CONTACT