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BRIEF TITLE: Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

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

  • Org Study ID: 1100
  • Secondary ID:
  • NCT ID: NCT03589339
  • NCT Alias:
  • Sponsor: Nanobiotix - Industry
  • Source: Nanobiotix

Brief Summary

The 1100 study is an open-label, Phase I, 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. The first
cohort includes patients with LRR or R/M HNSCC with the target lesion in a previously
irradiated field. In cohorts two and three, patients present with lung or liver metastases
from any primary cancer eligible for 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 until the end of the

Overal Status Start Date Phase Study Type
Recruiting January 16, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Determination of the Recommended Dose

Primary Outcome 1 - Time Frame: 24 Months


  • Radiotherapy
  • Immunotherapy
  • Microsatellite Instability-High Solid Malignant Tumour
  • Metastasis From Malignant Tumor of Stomach (Disorder)
  • Squamous Cell Carcinoma of Head and Neck
  • Metastasis From Malignant Tumor of Cervix
  • Metastatic Squamous Cell Carcinoma
  • Metastasis From Malignant Melanoma of Skin (Disorder)
  • Merkel Cell Carcinoma (Disorder)
  • Metastasis From Malignant Tumor of Lung
  • Metastasis From Malignant Tumor of Bladder (Disorder)


Inclusion Criteria:

- Signed informed consent form

- Biopsy-confirmed cancer diagnosis indicated to received anti-PD-1 therapy

- Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve) or is currently
receiving anti-PD-1 therapy and can be considered an anti-PD-1 non-responder (per SITC

- Has at least one tumor lesion that can be accurately measured according to RECIST 1.1.
and is amenable for intratumoral injection

- ECOG performance status 0-2

- Life expectancy >12 weeks

- Adequate organ and bone marrow function

- Negative pregnancy test ≤ 7 days prior to NBTXR3 injection in all female participants
of child-bearing potential

Exclusion Criteria:

- History of severe immune-related adverse events related to administration of anti-PD-1

- Symptomatic central nervous system metastases and/or carcinomatous meningitis

- Active autoimmune disease that has required systemic treatment in the past 2 years

- Known HIV or active hepatitis B/C infection

- Active infection requiring systemic treatment

- Received a live virus vaccine within 30 days prior to study treatment

- History of pneumonitis that required steroids or with current pneumonitis

- Extensive metastatic disease burden considered to be unamenable for radiation

- Locoregional recurrent HNSCC with ulceration

- Has received prior therapy with a checkpoint inhibitor, within 4 weeks prior to NBTXR3

- Has received prior systemic anti-neoplastic therapy, including investigational agents,
within 4 weeks prior to NBTXR3 injection

- Has not recovered from AEs due to previous anti-neoplastic therapies and/or
interventions (including radiation) to ≤ Grade 1 or baseline at screening

- Clinically significant cardiac arrhythmias

- Class III or IV Congestive Heart Failure as defined by the New York Heart Association
functional classification system < 6 months prior to screening

- A pregnant or nursing female, or women of child-bearing potential and men who are
sexually active and not willing/able to use medically acceptable forms of

- Any condition for which participation would not be in the best interest of the
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Elsa Borghi, MD

Role: Study Director

Affiliation: Nanobiotix

Overall Contact

Name: Katherine JAMESON, PhD

Phone: +1 (650) 796-9568



Facility Status Contact
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Recruiting Jiaxin Niu, MD, PhD

The University of Arizona Cancer Center
Tucson, Arizona 85719
United States
Recruiting Monstaser Shaheen, MD

Christiana Care Health Services
Newark, Delaware 19713
United States
Recruiting Michael Gaurino, MD

Moffitt Cancer Center
Tampa, Florida 33612
United States
Recruiting Jessica Frakes, MD

University of Chicago Medical Center
Chicago, Illinois 60637
United States
Recruiting Ari Rosenberg, MD

University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky 40202
United States
Recruiting Rebecca Redman, MD

Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Recruiting Tanguy Seiwert, MD

Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Recruiting Theodore Hong, MD

Quantum Santa Fe
Santa Fe, New Mexico 87505
United States
Recruiting Olivier Rixe, MD

University of North Carolina, School of Medicine
Chapel Hill, North Carolina 27516
United States
Recruiting Colette Shen, MD, PhD