NCT03589339

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Nanobiotix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	NBTXR3	Single intra Tumoral injection
RADIATION	SABR	Radiotherapy given as a definite number of fractions at the dose defined for each radiation field
DRUG	Nivolumab	Anti-PD-1 monotherapy
DRUG	Pembrolizumab	Anti-PD-1 monotherapy

Timeline

• Start date: 2019-01-16
• Primary completion: 2027-04-30
• Completion: 2027-08-30
• First posted: 2018-07-17
• Last updated: 2025-10-24

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study