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

Trial Status: Active

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.

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 guidelines)
  • 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 treatment
  • Locoregional recurrent HNSCC with ulceration
  • Has received prior therapy with a checkpoint inhibitor, within 4 weeks prior to NBTXR3 injection
  • 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 contraception
  • Any condition for which participation would not be in the best interest of the participant


Banner University Medical Center - Tucson
Status: ACTIVE


Moffitt Cancer Center
Status: ACTIVE


University of Chicago Comprehensive Cancer Center
Status: ACTIVE


Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE


Massachusetts General Hospital Cancer Center
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center

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


Trial Phase Phase I

Trial Type Treatment

Lead Organization

  • Primary ID 1100
  • Secondary IDs NCI-2019-03108, NBTXR3-1100
  • ID NCT03589339