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

Immunotherapy Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Immunotherapy
• Liver Neoplasms
• Melanoma
• Metastasis From Malignant Melanoma of Skin (Disorder)
• Metastasis From Malignant Tumor of Bladder (Disorder)
• Metastasis From Malignant Tumor of Cervix
• Metastatic NSCLC
• Metastatic Renal Cell Carcinoma
• Metastatic Triple-Negative Breast Carcinoma
• Microsatellite Instability
• Microsatellite Instability-High Solid Malignant Tumour
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Radiotherapy
• Squamous Cell Carcinoma of Head and Neck
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

• NCT number: NCT03589339
• Study type: Interventional
• Source: Nanobiotix
• Contact: Pavel Tyan, MD
• Phone: +49 176 81319375
• Email: pavel.tyan@nanobiotix.com
• Status: Recruiting
• Phase: Phase 1
• Start date: January 16, 2019
• Completion date: May 30, 2028