A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer — Tumorad  

Solid Tumor Clinical Trial

Official title: A Phase I/IIa, Dose Escalation and Dose Expansion, First-in-human, Open-label, Multicenter, Single-arm Study Evaluating the Safety, Tolerability, Dosimetry, and Early Efficacy of [177Lu]Lu-SN201 in Participants With Progressive or Treatment-refractory Locally Advanced Unresectable, Metastatic or Recurrent Solid Tumors

Status Recruiting

Clinical Trial Summary

The purpose of this first-in-human (FIH) study is to determine the maximum tolerated dose (MTD) and to characterize the safety, tolerability, PK, and dosimetry profile of [177Lu]Lu-SN201 in adult participants with advanced solid tumors who have no standard of care treatment options.

[177Lu]Lu-SN201 is a radiolabeled, nanomedical investigational medicinal product (IMP) whose mechanism of delivery is based on the Enhanced Permeability and Retention (EPR) effect.

Clinical Trial Description

Eligible participants will receive [177Lu]Lu-SN201 via slow intravenous infusion on Cycle 1 Day 1. Participants will initially receive one cycle of treatment and will progress to a 2nd and 3rd cycle of treatment, provided retreatment criteria are met before the start of each cycle. The dosing schedule visit frequency will be every 6 weeks (with an allowable window to delay each cycle by +3 weeks per retreatment criteria), each participant may receive up to 3 cycles, with the treatment duration up to 22 weeks. A total of 3 treatment cycles will be given unless the participant meets early discontinuation criteria. For Cycle 1, an overnight hospitalization for standard-of-care observation following Day 1 clinic assessments to Day 2 is mandatory for all participants receiving Cycle 1.

Whole-body planar imaging, and single photon emission computed tomography (SPECT)/computed tomography (CT) will be performed post-administration of [177Lu]Lu-SN201 to assess biodistribution and dosimetry. CT or magnetic resonance imaging (MRI) will be used to assess the response of the disease to treatment using Response Evaluation Criteria (RECIST v1.1).

The general procedures for participants in Phase I and Phase IIa are summarized below:

• Baseline values are defined as the last collected value prior to the start of infusion.

• Continual assessment of adverse events (AEs) and concomitant medication usage will be conducted.

• Whole-body planar on Day 1, Day 2, Day 4, and Day 8 and SPECT/CT on Day 2, Day 4 and Day 8 will be used for biodistribution and dosimetry evaluation of all participants. If dosimetry has been met by previous participants at each dose level, the DMC may partly or fully exclude the requirement for dosimetry procedures in remaining participants at this dose level.

• For participants that will continue to treatment Cycle 2 or 3, eligibility assessment and IMP procurement will take place within the coming 17 days. ;

Related Conditions & MeSH terms

• Locally Advanced Solid Tumor
• Metastatic Cancer
• Neoplasms
• Recurrent Solid Tumor
• Refractory Cancer
• Solid Tumor

• NCT number: NCT06184035
• Study type: Interventional
• Source: Spago Nanomedical AB
• Contact: Chief Development Officer
• Phone: +46 46 81188
• Email: info@spagonanomedical.se
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 30, 2023
• Completion date: December 31, 2027