NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

Summary

Objectives

The 1100 study aims to evaluate the safety, efficacy, and tolerability of NBTXR3 activated by
radiotherapy in combination with an anti-PD-1 therapy in three cohorts of patients in dose
escalation and expansion parts. The Escalation Cohort 1 includes patients with LRR or R/M
HNSCC with the injectable lesion in a previously irradiated field. In Escalation Cohorts 2
and 3, patients present with lung or liver metastases from any primary cancer eligible for
anti-PD-1 therapy.

The Expansion cohort 1 includes patients with LRR or R/M HNSCC with the injectable lesion
located either in head and neck area or in lung or liver, who are resistant to anti-PD-1
therapy. The Expansion cohort 2 includes patients with LRR or R/M HNSCC with the injectable
lesion located either in head and neck area or in lung or liver, who are naive to anti-PD-1
therapy.

The Expansion Cohort 3 includes patients with inoperable NSCLC, malignant melanoma, HCC, RCC,
urothelial cancer, cervical cancer or TNBC with metastases to lungs, liver or soft tissue and
who are resistant to anti-PD-1 therapy.

These patients have a high unmet need and the Sponsor hypothesizes that NBTXR3 activated by
radiotherapy will act synergistically with anti-PD-1 to enhance the therapeutic index of
radiotherapy maximizing local effect, to overcome radio-resistance, to increase the local
efficacy of immunotherapy, and to improve distant tumor control via an abscopal effect.
Eligible patients will receive a single intratumoral injection of NBTXR3 subsequently
activated by radiotherapy and then an approved anti-PD-1. The end of treatment visit will
take place 4 weeks after the last radiotherapy fraction. Patients will be followed for
long-term safety and efficacy for 2 years after the EOT visit.