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

Recruiting Phase 1 Phase 2 Interventional Study
Solid Tumor Metastatic Cancer Unresectable Solid Tumor Recurrent Solid Tumor Locally Advanced Solid Tumor Refractory Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Spago Nanomedical AB · Industry
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About This Trial
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 deliv…
Trial Locations
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Eligibility Criteria
Inclusion criteria: 1. Male or female participants ≥ 18 years of age on the day of signing informed consent. 2. Histologically or cytologically documented, recurrent, locally advanced, or metastatic solid malignancy that has failed at least one prior systemic standard therapy, or for which standard…
Contacts

Chief Development Officer

+46 46 81188

info@spagonanomedical.se

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