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Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab

NBTXR3

Radiotherapy given as a definite number of fractions at the dose defined for each radiation field

SABR

Pavel Tyan, MD

Jason Chan, MD

George Yang, MD

William Stokes, MD

Ari Rosenberg, MD

Ammar Sukari, MD

Andrea Teague, MD

Bhupesh Parashar, MD

Colette Shen, MD, PhD

Nashat Gabrail, MD

William Smith, MD

Michele Lohr, MD

The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.

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.

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

A Phase I Dose Escalation / Dose Expansion Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

Determination of DLTs, the MTD (if possible), and RP2Ds for each cohort

Incidence of Grade 3 and higher treatment-related AEs

Evaluation of the Objective Response Rate: complete or partial response, as defined by RECIST 1.1 and iRECIST

Assessment of the number of participants with related late onset toxicities defined as any Grade ≥3 AE occurring after the EOT visit and determination of the number of participants with feasible NBTXR3 intratumoral injection

Evaluation of the time-course dependent accumulation of hafnium in blood and urine following NBTXR3 intratumoral injection

Nanobiotix

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy	NCT03589339	Radiotherapy Immunotherapy Microsatellite ... Metastasis From... Squamous Cell C... Metastasis From... Metastatic Rena... Metastasis From... Metastatic Trip... Metastatic NSCL... Metastasis From...	NBTXR3 SABR Nivolumab Pembrolizumab	18 Years -	Nanobiotix
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy	NCT03589339	Radiotherapy Immunotherapy Microsatellite ... Metastasis From... Squamous Cell C... Metastasis From... Metastatic Rena... Metastasis From... Metastatic Trip... Metastatic NSCL... Metastasis From...	NBTXR3 SABR Nivolumab Pembrolizumab	18 Years -	Nanobiotix

Spots Global Cancer Trial Database for metastasis from malignant melanoma of skin (disorder)