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.