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

NCT03589339 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2025-10-24

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • Nanobiotix

    lead INDUSTRY

Principal Investigators

  • Pavel Tyan, MD · Nanobiotix

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2027-04-30
Completion
2027-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03589339 on ClinicalTrials.gov