LUMINOS-103 | Istari Oncology

A basket trial of lerapolturev (formerly PVSRIPO) and lerapolturev in combination with anti–PD-1/L1 checkpoint inhibitors in multiple solid tumor types

LUMINOS-103 Study Design

DLT, dose-limiting toxicity; DSMC, Data Safety Monitoring Committee; HNSCC, head and neck squamous cell cancer; MIBC, muscle-invasive bladder cancer.

LUMINOS-103 Study Design

DLT, dose-limiting toxicity; DSMC, Data Safety Monitoring Committee; HNSCC, head and neck squamous cell cancer; MIBC, muscle-invasive bladder cancer.

LUMINOS-103 (NCT04690699) is a multicenter, open-label, single-arm phase 1/2 basket study investigating the efficacy and safety of lerapolturev in several solid tumor types. The study enrolled its first patient in October 2021 and is ongoing at a rapidly expanding list of US sites.

Cohort

Tumor type

Setting

A

MIBC

Neoadjuvant treatment of patients with MIBC who refuse or are ineligible for cisplatin

B

MIBC

First-line treatment of unresectable or metastatic MIBC

C

HNSCC

Neoadjuvant treatment of patients with resectable, locally advanced HNSCC

D

HNSCC

First-line treatment of unresectable or metastatic HNSCC

The phase 1 part of each study will include approximately 6 patients with each tumor type, who will be evaluated for safety. Once approved by the DSMC, the phase 2 part of the study will enroll approximately 25 patients in each cohort.

Infographic of LUMINOS-103 bladder cohorts

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with more information, including entry criteria and study endpoints for patients with MIBC

Download an infographic
with more information, including entry criteria and study endpoints for patients with other tumor types, including HNSCC

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Please contact us or email LUMINOS-103@istarioncology.com.

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